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Parallel Study Design Example (With Results)
Disclaimer: The following information is fictional and is only intended for the purpose of illustrating key
concepts for results data entry in the Protocol Registration and Results System (PRS).
[Link] Identifier: NCT00055555
The safety and scientific validity of this study is
the responsibility of the study sponsor and
Recruitment Status: Completed
! investigators. Listing a study does not mean it First Posted: March 1, 2017
has been evaluated by the U.S. Federal Results First Posted: May 30, 2019
Government. Read our disclaimer for details. Last Update Posted: May 30, 2019
Sponsor:
PRS Results Training
Information provided by (Responsible Party):
PRS Results Training
Study Description
Brief Summary:
The purpose of this study is to assess the safety and efficacy of Remuverol for treatment of disc
herniation.
Condition or disease Intervention/treatment Phase
Herniated Disc Drug: Remuverol Phase 3
Drug: Placebo
Detailed Description:
After being informed about the study and potential risks, all patients giving written informed consent will
undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet
the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a
1:1 ratio to Remuverol (15 mg, twice daily) or placebo (twice daily).
Parallel Study Design Example 1 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Study Design
\
Study Type: Interventional
Actual Enrollment: 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 24-Week Double-Blind Trial of Remuverol in Adults With Disc
Herniation
Actual Study Start Date: March 1, 2017
Actual Primary Completion Date: June 1, 2018
Actual Study Completion Date: August 1, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Remuverol Drug: Remuverol
Participants received Remuverol 15 mg tablet orally twice daily for 15 mg tablet
24 weeks.
Placebo Comparator: Placebo Drug: Placebo
Participants received Remuverol placebo tablet matching Remuverol placebo
Remuverol orally twice daily for 24 weeks. tablet
Outcome Measures
Primary Outcome Measure:
1. Change From Baseline in Pain on the 11-point Short Pain Scale (SPS-11) at Week 24 [ Time
Frame: Baseline and Week 24 ]
SPS-11 is a validated, self-reported instrument assessing average pain intensity over the past 24
hour period. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week
24 Score - Baseline Score).
Parallel Study Design Example 2 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Secondary Outcome Measures:
1. Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [ Time
Frame: 12 weeks ]
The response rate was defined as the number of participants with a 50% or greater reduction in
SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-reported instrument
assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no
pain) to 10 (worst possible pain).
2. Response Rate - 50 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [ Time
Frame: 24 weeks ]
The response rate was defined as the number of participants with a 50% or greater reduction in
SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-reported instrument
assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no
pain) to 10 (worst possible pain).
3. Response Rate - 75 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score [ Time
Frame: 24 weeks ]
The response rate was defined as the number of participants with a 75% or greater reduction in
SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-reported instrument
assessing average pain intensity over the past 24 hour period. Possible scores range from 0 (no
pain) to 10 (worst possible pain).
Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
• Outpatients
• At least 18 years of age
• Had disc herniation for at least 6 months before the study. Disc herniation was diagnosed based on
medical history and neurological examination.
• A sufficient level of education to understand study procedures and be able to communicate with site
personnel
Parallel Study Design Example 3 of 19 January 2020
(With Results)
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Exclusion Criteria:
• Any cardiovascular, hepatic, or renal conditions that would compromise participation (e.g.,
hospitalization during the study), in the opinion of the investigator
• History of acute liver injury (e.g., hepatitis) or severe cirrhosis
• Body Mass Index (BMI) of >40 kg/m^2
• Pregnancy
• Breast-feeding
• Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen
• Current use of narcotics
Contacts and Locations
Locations
United States, Maryland
NIH
Bethesda, Maryland, United States, 20892
Canada, Quebec
McGill University
Montreal, Quebec, Canada
Mexico
University of Quintana Roo
Cozumel, Mexico
Study Documents (Full-Text)
Documents provided by PRS Results Training
Study Protocol and Statistical Analysis Plan [PDF] February 1, 2016
More Information
Responsible Party: PRS Results Training
[Link] Identifier: NCT00055555
Other Study ID Numbers: TTTParallelR
First Posted: March 1, 2017
Parallel Study Design Example 4 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019
Last Verified: May 2019
Human Subjects Protection Review Board Status: Approved
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Study Results
Study Type Interventional
Allocation: Randomized; Intervention Model: Parallel Assignment;
Study Design
Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition Herniated Disc
Drug: Remuverol
Interventions
Drug: Placebo
Enrollment 205
Participant Flow
Participants were recruited based on physician referral at 3 academic medical
centers between February 2017 and January 2018. The first participant was
Recruitment Details
enrolled on March 1, 2017 and the last participant was enrolled in December
2017.
Of 205 enrolled participants, 200 met inclusion criteria and were randomized to
Pre-assignment Details
treatment.
Parallel Study Design Example 5 of 19 January 2020
(With Results)
[Link] is a service of the
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Arm/Group Title Remuverol Placebo
Arm/Group Description Participants received Participants received Remuverol
Remuverol 15 mg tablet orally placebo tablet matching
twice daily for 24 weeks. Remuverol orally twice daily for
Remuverol: 15 mg tablet 24 weeks.
Placebo: Remuverol placebo
tablet
Period Title: Overall Study
Started 101 99
Per Protocol Population Week 12 98 95
Per Protocol Population Week 24 76 81
Completed 80 81
Not Completed 21 18
Reason Not Completed
Adverse Event 10 8
Withdrawal by Subject 5 4
Protocol Violation 2 2
Lack of Efficacy 1 1
Physician Decision 1 1
Lost to Follow-up 1 2
Pregnancy 1 0
Parallel Study Design Example 6 of 19 January 2020
(With Results)
[Link] is a service of the
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Baseline Characteristics
Arm/Group Title Remuverol Placebo Total
Arm/Group Description Participants Participants received Total of all
received Remuverol Remuverol placebo reporting groups
15 mg tablet orally tablet matching
twice daily for 24 Remuverol orally
weeks. twice daily for 24
Remuverol: 15 mg weeks.
tablet Placebo: Remuverol
placebo tablet
Overall Number of Baseline
101 99 200
Participants
Baseline Analysis Population [Not Specified]
Description
Age,
Continuous
Mean (Standard
Deviation)
Unit of Measure:
years
Number Analyzed 101 participants 99 participants 200 participants
34.78 (9.72) 35.34 (10.71) 35.06 (10.23)
Sex: Female,
Male
Measure Type:
Count of
Participants
Unit of measure:
participants
Number Analyzed 101 participants 99 participants 200 participants
Female 60 59.41% 63 63.64% 123 61.5%
Male 41 40.59% 36 36.36% 77 38.5%
Parallel Study Design Example 7 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Ethnicity
(NIH/OMB)
Measure Type:
Count of
Participants
Unit of measure:
participants
Number Analyzed 101 participants 99 participants 200 participants
Hispanic or Latino 5 4.95% 4 4.04% 9 4.5%
Not Hispanic or 96 95.05% 95 95.96% 191 95.5%
Latino
Unknown or Not 0 0% 0 0% 0 0%
Reported
Race
(NIH/OMB)
Measure Type:
Count of
Participants
Unit of measure:
participants
Number Analyzed 101 participants 99 participants 200 participants
American Indian or 1 0.99% 1 1.01% 2 1%
Alaska Native
Asian 0 0% 0 0% 0 0%
Native Hawaiian or 0 0% 0 0% 0 0%
Other Pacific
Islander
Black or African 5 4.95% 4 4.04% 9 4.5%
American
White 95 94.06% 94 94.95% 189 94.5%
More than one race 0 0% 0 0% 0 0%
Unknown or Not 0 0% 0 0% 0 0%
Reported
Parallel Study Design Example 8 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Region of Number Analyzed 101 participants 99 participants 200 participants
Enrollment
Measure Type:
Count of
Participants
Unit of measure:
participants
Canada 35 34.65% 35 35.35% 70 35%
United States 44 43.56% 47 47.47% 91 45.5%
Mexico 22 21.78% 17 17.17% 39 19.5%
Quebec Task
Force
Classification
of Spinal
Disorders [1]
Measure Type:
Count of
Participants
Unit of measure:
participants
Number Analyzed 101 participants 99 participants 200 participants
Class 0 (no pain) 16 15.84% 14 14.14% 30 15%
Class 1 (pain 73 72.28% 68 68.69% 141 70.5%
without radiation)
Class 2 (pain with 12 11.88% 17 17.17% 29 14.5%
proximal extremity
radiation)
[1] Measure Description: Quebec Task Force (QTF)
Classification of Spinal Disorders consists of 8 classes
ranging from Class 0 (no pain) to Class 7 (spinal stenosis).
Parallel Study Design Example 9 of 19 January 2020
(With Results)
[Link] is a service of the
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Body Mass
Index
Mean (Standard
Deviation)
Unit of measure:
kg/m^2
Number Analyzed 101 participants 99 participants 200 participants
26.65 (4.50) 27.41 (4.72) 27.03 (4.63)
Short Pain
Scale (SPS-
11) Score [1]
Mean (Standard
Deviation)
Unit of measure:
units on a scale
Number Analyzed 101 participants 99 participants 200 participants
6.48 (1.34) 6.57 (1.73) 6.52 (1.55)
[1] Measure Description: SPS-11 is a validated, self-reported
instrument assessing average pain intensity over the past 24
hr period. The severity of pain on the SPS-11 ranges from 0
(no pain) to 10 (worst possible pain).
Duration of
Disc Herniation
Mean (Standard
Deviation)
Unit of measure:
years
Number Analyzed 101 participants 99 participants 200 participants
3.82 (3.18) 3.47 (2.95) 3.65 (3.07)
Parallel Study Design Example 10 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Height
Mean (Standard
Deviation)
Unit of measure:
cm
Number Analyzed 101 participants 99 participants 200 participants
186.42 (9.46) 176.91 (8.28) 181.71 (10.09)
Weight
Mean (Standard
Deviation)
Unit of measure:
kg
Number Analyzed 101 participants 99 participants 200 participants
77.03 (14.38) 78.53 (13.56) 77.77 (14.00)
Outcome Measures
1. Primary Outcome
Title Change From Baseline in Pain on the 11-point Short Pain Scale (SPS-11) at Week 24
Description SPS-11 is a validated, self-reported instrument assessing average pain intensity over the
past 24 hour period. Possible scores range from 0 (no pain) to 10 (worst possible pain).
Change = (Week 24 Score – Baseline Score).
Time Frame Baseline and Week 24
Outcome Measure Data
Analysis Population Description
Intent to Treat population (all participants assigned to Remuverol or Placebo). Last observation carried
forward (LOCF) imputation method.
Parallel Study Design Example 11 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Arm/Group Title Remuverol Placebo
Arm/Group Description: Participants received Remuverol 15 Participants received Remuverol
mg tablet orally twice daily for 24 placebo tablet matching Remuverol
weeks. orally twice daily for 24 weeks.
Remuverol: 15 mg tablet Placebo: Remuverol placebo tablet
Overall Number of 101 99
Participants Analyzed
Mean (Standard Deviation) -3.84 (0.61) -2.08 (0.51)
Unit of Measure: units on a
scale
Statistical Analysis 1
Statistical Comparison Group Remuverol, Placebo
Analysis Selection
Overview Comments It was calculated that 200 participants randomized in a 1:1
fashion between the 2 arms would have at least 85% power
to detect a difference of 0.56 points in mean SPS-11 pain
score between Remuverol and placebo from baseline to
week 24. Sample size was determined using a 2-sided 2-
sample t test (α = 0.05). Assumptions included a common
standard deviation of 1.14 and a discontinuation rate of 7%.
Type of Statistical Superiority
Test
Comments [Not specified]
Statistical P-Value 0.002
Test of Comments The threshold for statistical significance was p = 0.05.
Hypothesis
Method Mixed Models Analysis
Comments [Not specified]
Parallel Study Design Example 12 of 19 January 2020
(With Results)
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National Institutes of Health.
Method of Estimation
Mean Difference (Net)
Estimation Parameter
Estimated Value -1.76
Parameter Type:Standard Deviation
Dispersion Value: 0.80
Estimation
Treatment Difference = Remuverol - Placebo
Comments
2. Secondary Outcome
Title Response Rate - 50 Percent or Greater Reduction in Short Pain Scale
(SPS-11) Score
Description The response rate was defined as the number of participants with a 50% or greater
reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-
reported instrument assessing average pain intensity over the past 24 hour period.
Possible scores range from 0 (no pain) to 10 (worst possible pain).
Time Frame 12 weeks
Outcome Measure Data
Analysis Population Description
Per-protocol population (all participants with baseline and week 12 pain scores available).
Arm/Group Title Remuverol Placebo
Arm/Group Description: Participants received Remuverol 15 Participants received Remuverol
mg tablet orally twice daily for 24 placebo tablet matching Remuverol
weeks. orally twice daily for 24 weeks.
Remuverol: 15 mg tablet Placebo: Remuverol placebo tablet
Overall Number of 98 95
Participants Analyzed
Measure Type: Count of 45 45.92% 37 38.95%
Participants
Unit of Measure: participants
Parallel Study Design Example 13 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Statistical Analysis 1
Statistical Comparison Group Remuverol, Placebo
Analysis Selection
Overview Comments [Not specified]
Type of Statistical Superiority
Test
Comments [Not specified]
Statistical P-Value 0.383
Test of Comments [Not specified]
Hypothesis
Method Fisher Exact
Comments [Not specified]
3. Secondary Outcome
Title Response Rate - 50 Percent or Greater Reduction in Short Pain Scale
(SPS-11) Score
Description The response rate was defined as the number of participants with a 50% or greater
reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-
reported instrument assessing average pain intensity over the past 24 hour period.
Possible scores range from 0 (no pain) to 10 (worst possible pain).
Time Frame 24 weeks
Outcome Measure Data
Analysis Population Description
Per-protocol population (all participants with baseline and week 24 pain scores available).
Parallel Study Design Example 14 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Arm/Group Title Remuverol Placebo
Arm/Group Description: Participants received Remuverol 15 Participants received Remuverol
mg tablet orally twice daily for 24 placebo tablet matching Remuverol
weeks. orally twice daily for 24 weeks.
Remuverol: 15 mg tablet Placebo: Remuverol placebo tablet
Overall Number of 76 81
Participants Analyzed
Measure Type: Count of 73 96.05% 67 82.72%
Participants
Unit of Measure: participants
Statistical Analysis 1
Statistical Comparison Group Remuverol, Placebo
Analysis Selection
Overview Comments [Not specified]
Type of Statistical Superiority
Test
Comments [Not specified]
Statistical P-Value 0.009
Test of Comments [Not specified]
Hypothesis
Method Fisher Exact
Comments [Not specified]
Parallel Study Design Example 15 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
4. Secondary Outcome
Title Response Rate - 75 Percent or Greater Reduction in Short Pain Scale (SPS-11) Score
Description The response rate was defined as the number of participants with a 75% or greater
reduction in SPS-11 pain score from baseline to endpoint. SPS-11 is a validated, self-
reported instrument assessing average pain intensity over the past 24 hour period.
Possible scores range from 0 (no pain) to 10 (worst possible pain).
Time Frame 24 weeks
Outcome Measure Data
Analysis Population Description
Per-protocol population (all participants with baseline and week 24 pain scores available).
Arm/Group Title Remuverol Placebo
Arm/Group Description: Participants received Remuverol 15 Participants received Remuverol
mg tablet orally twice daily for 24 placebo tablet matching Remuverol
weeks. orally twice daily for 24 weeks.
Remuverol: 15 mg tablet Placebo: Remuverol placebo tablet
Overall Number of 76 81
Participants Analyzed
Measure Type: Count of 57 75% 32 39.51%
Participants
Unit of Measure: participants
Statistical Analysis 1
Statistical Comparison Group Remuverol, Placebo
Analysis Selection
Overview Comments [Not Specified]
Type of Statistical Superiority
Test
Comments [Not Specified]
Parallel Study Design Example 16 of 19 January 2020
(With Results)
[Link] is a service of the
National Institutes of Health.
Statistical P-Value 0.006
Test of Comments [Not Specified]
Hypothesis
Method Fisher Exact
Comments [Not Specified]
Adverse Events
Time Frame 32 Weeks
Adverse Event Reporting Description
Source Vocabulary Name for Table Default MedDRA (12.0)
Collection Approach for Table Default Systematic Assessment
Arm/Group Title Remuverol Placebo
Arm/Group Description Participants received Participants received
Remuverol 15 mg tablet orally Remuverol placebo tablet
twice daily for 24 weeks. matching Remuverol orally
Remuverol: 15 mg tablet twice daily for 24 weeks.
Placebo: Remuverol placebo
tablet
All-Cause Mortality
Remuverol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total 0/101 (0%) 0/99 (0%)
Parallel Study Design Example 17 of 19 January 2020
(With Results)
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National Institutes of Health.
Serious Adverse Events
Remuverol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total 4/101 (3.96%) 0/99 (0%)
Blood and lymphatic system disorders
†1
Anemia iron deficiency 1/101 (0.99%) 0/99 (0%)
†1
Idiopathic thrombocytopenic purpura 1/101 (0.99%) 0/99 (0%)
Immune system disorders
†1
Viral meningitis 1/101 (0.99%) 0/99 (0%)
Skin and subcutaneous tissue disorders
†1
Psoriasis 1/101 (0.99%) 0/99 (0%)
1 Term from vocabulary, MedDRA (12.0)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other 1%
Adverse Events
Remuverol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total 98/101 (97.03%) 46/99 (46.46%)
Ear and labyrinth disorders
†1
Earache 35/101 (34.65%) 7/99 (7.07%)
Endocrine disorders
†1
Hypothyroidism 27/101 (26.73%) 25/99 (25.25%)
Eye disorders
†1
Conjunctivitis 13/101 (12.87%) 4/99 (4.04%)
Gastrointestinal disorders
†1
Nausea 12/101 (11.88%) 7/99 (7.07%)
†1
Stomachache 10/101 (9.9%) 2/99 (2.02%)
†1
Vomiting 10/101 (9.9%) 3/99 (3.03%)
1 Term from vocabulary, MedDRA (12.0)
† Indicates events were collected by systematic assessment
Parallel Study Design Example 18 of 19 January 2020
(With Results)
[Link] is a service of the
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Limitations and Caveats
The actual discontinuation rate was higher than expected/anticipated. Therefore, the analysis of the primary
outcome measure, a change from baseline to week 24 in the SPS-11 24-hour pain score, was under-
powered.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: PRS Training Lead
Organization: PRS Results Training
Phone: 555-555-5555
Email: register@[Link]
Responsible Party: PRS Results Training
[Link] Identifier: NCT00055555
Other Study ID Numbers: TTTParallelR
First Submitted: February 25, 2017
First Posted: March 1, 2017
Results First Submitted: May 1, 2019
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019
Parallel Study Design Example 19 of 19 January 2020
(With Results)
