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Trial record 2 of 46 for:    CYCLOBENZAPRINE

Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02814565
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Neck Pain
Back Pain
Spasm
Interventions Drug: Cyclobenzaprine HCl
Drug: Placebo
Enrollment 180
Recruitment Details Participants took part in the study at 10 investigative sites in the Russian Federation from 12 October 2016 to 14 March 2017.
Pre-assignment Details Participants with a diagnosis of acute cervical and/or lower back pain due to muscle spasms of local origin were enrolled equally in one of two treatment groups: Cyclobenzaprine HCl 15 mg or placebo.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Period Title: Overall Study
Started 90 90
Completed 89 88
Not Completed 1 2
Reason Not Completed
Lack of Efficacy             0             1
Subject decision, caused by AE Influenza             1             1
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo Total
Hide Arm/Group Description Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 90 90 180
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 90 participants 180 participants
33.0  (9.0) 31.5  (9.2) 32.3  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 90 participants 180 participants
Female
48
  53.3%
62
  68.9%
110
  61.1%
Male
42
  46.7%
28
  31.1%
70
  38.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
European (Caucasian) Number Analyzed 90 participants 90 participants 180 participants
90
 100.0%
90
 100.0%
180
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Russia Number Analyzed 90 participants 90 participants 180 participants
90
 100.0%
90
 100.0%
180
 100.0%
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 90 participants 180 participants
Never smoked
78
  86.7%
79
  87.8%
157
  87.2%
Former smoker
1
   1.1%
3
   3.3%
4
   2.2%
Current smoker
11
  12.2%
8
   8.9%
19
  10.6%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 90 participants 90 participants 180 participants
171.8  (8.2) 169.1  (7.6) 170.5  (8.0)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 90 participants 90 participants 180 participants
71.05  (14.53) 66.22  (13.61) 68.64  (14.25)
1.Primary Outcome
Title Percentage of Participants With Subject’s Rating of Medication Helpfulness Impression on Day 3 of Treatment
Hide Description Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 3, 0=poor 20.0 28.9
Day 3, 1=fair 60.0 46.7
Day 3, 2=good 16.7 22.2
Day 3, 3=very good 3.3 2.2
Day 3, 4=excellent 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6179
Comments [Not Specified]
Method Wilcoxon Rank Sum test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Subject’s Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
Hide Description Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: "How would you rate this study medication in improving your condition?" "0 = poor", "1 = fair", "2 = good", "3 = very good", "4 = excellent".
Time Frame Days 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 7, 0=poor 7.8 16.7
Day 7, 1=fair 41.1 34.4
Day 7, 2=good 35.6 34.4
Day 7, 3=very good 13.3 11.1
Day 7, 4=excellent 2.2 3.3
Day 14, 0=poor 8.9 14.4
Day 14, 1=fair 25.6 25.6
Day 14, 2=good 25.6 28.9
Day 14, 3=very good 22.2 20.0
Day 14, 4=excellent 17.8 11.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4338
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 14. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1657
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
Hide Description The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 3, 1=worse 1.1 0.0
Day 3, 2=no change 52.2 68.9
Day 3, 3=slight improvement 35.6 25.6
Day 3, 4=moderate improvement 11.1 3.3
Day 3, 5=marked improvement 0.0 2.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0393
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
Hide Description The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Time Frame Days 7 and 15
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 7, 1=worse 2.2 0.0
Day 7, 2=no change 8.9 26.7
Day 7, 3=slight improvement 52.2 44.4
Day 7, 4=moderate improvement 27.8 24.4
Day 7, 5=marked improvement 8.9 4.4
Day 15, 1=worse 1.1 1.1
Day 15, 2=no change 5.6 11.1
Day 15, 3=slight improvement 27.8 34.4
Day 15, 4=moderate improvement 30.0 32.2
Day 15, 5=marked improvement 35.6 21.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0330
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0262
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
Hide Description Participants assessed their clinical global impression based on relief from local pain, restriction in activities of daily living, restriction of movement and intensity of local pain on a daily basis. The following 5-point rating scale was used: "1 = worse", "2 = no change", "3 = slight improvement", "4 = moderate improvement", "5 = marked improvement".
Time Frame Days 3, 7, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 3, 1=worse 3.3 1.1
Day 3, 2=no change 45.6 56.7
Day 3, 3=slight improvement 47.8 33.3
Day 3, 4=moderate improvement 3.3 7.8
Day 3, 5=marked improvement 0.0 1.1
Day 7, 1=worse 4.4 1.1
Day 7, 2=no change 13.3 25.6
Day 7, 3=slight improvement 52.2 43.3
Day 7, 4=moderate improvement 22.2 25.6
Day 7, 5=marked improvement 7.8 4.4
Day 14, 1=worse 1.1 1.1
Day 14, 2=no change 14.4 26.7
Day 14, 3=slight improvement 24.4 20.0
Day 14, 4=moderate improvement 27.8 28.9
Day 14, 5=marked improvement 32.2 23.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5756
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4395
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 14. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0905
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Responders on Days 3, 7, and 14 of Treatment
Hide Description A responder was defined as a participant who had both a rating of either "very good" or "excellent" for the participant's rating of medication helpfulness.
Time Frame Days 3, 7, and 14
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 3 3.3 2.2
Day 7 15.6 14.4
Day 14 40.0 31.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 3. A two-tailed Fisher's exact test to compare the number of "responders" between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. A two-tailed Fisher's exact test to compare the number of "responders" between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 14. A two-tailed Fisher's exact test to compare the number of "responders" between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2757
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
Hide Description The investigator assessment based on physical examination, presence of muscle spasm (presence of muscle spasm assessment). The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe”.
Time Frame Days 3, 7, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 3, 1=none 2.2 2.2
Day 3, 2=mild 27.8 21.1
Day 3, 3=moderate 62.2 66.7
Day 3, 4=moderately severe 7.8 10.0
Day 3, 5=severe 0.0 0.0
Day 7, 1=none 14.4 5.6
Day 7, 2=mild 47.8 53.3
Day 7, 3=moderate 37.8 38.9
Day 7, 4=moderately severe 0.0 2.2
Day 7, 5=severe 0.0 0.0
Day 15, 1=none 48.9 32.2
Day 15, 2=mild 37.8 47.8
Day 15, 3=moderate 13.3 20.0
Day 15, 4=moderately severe 0.0 0.0
Day 15, 5=severe 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3020
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2367
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0250
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
Hide Description The investigator assessed local pain based on physical examination, reaction to palpation (presence of local pain assessment). The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe”.
Time Frame Days 3, 7, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 3, 1=none 1.1 1.1
Day 3, 2=mild 24.4 21.1
Day 3, 3=moderate 66.7 66.7
Day 3, 4=moderately severe 7.8 11.1
Day 3, 5=severe 0.0 0.0
Day 7, 1=none 6.7 2.2
Day 7, 2=mild 55.6 50.0
Day 7, 3=moderate 36.7 46.7
Day 7, 4=moderately severe 1.1 1.1
Day 7, 5=severe 0.0 0.0
Day 15, 1=none 35.6 25.6
Day 15, 2=mild 51.1 50.0
Day 15, 3=moderate 12.2 24.4
Day 15, 4=moderately severe 1.1 0.0
Day 15, 5=severe 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4428
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1163
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0489
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
Hide Description The investigator assessed limitation of range of motion. The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe”.
Time Frame Days 3, 7, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of participants
Day 3, 1=none 6.7 4.4
Day 3, 2=mild 40.0 37.8
Day 3, 3=moderate 47.8 52.2
Day 3, 4=moderately severe 5.6 5.6
Day 3, 5=severe 0.0 0.0
Day 7, 1=none 22.2 13.3
Day 7, 2=mild 51.1 51.1
Day 7, 3=moderate 26.7 35.6
Day 7, 4=moderately severe 0.0 0.0
Day 7, 5=severe 0.0 0.0
Day 15, 1=none 44.4 38.9
Day 15, 2=mild 48.9 47.8
Day 15, 3=moderate 6.7 13.3
Day 15, 4=moderately severe 0.0 0.0
Day 15, 5=severe 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5275
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0880
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2542
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
Hide Description The investigator assessed limitation of activities based on evaluation of the patient's reported functional assessment. The following 5-point rating scale was used: "1 = none", "2 = mild", "3 = moderate", "4 = moderately severe", "5 = severe”.
Time Frame Days 3, 7, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description:
Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days.
Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
Overall Number of Participants Analyzed 90 90
Measure Type: Number
Unit of Measure: percentage of percentage
Day 3, 1=none 4.4 5.6
Day 3, 2=mild 46.7 50.0
Day 3, 3=moderate 46.7 38.9
Day 3, 4=moderately severe 2.2 5.6
Day 3, 5=severe 0.0 0.0
Day 7, 1=none 18.9 10.0
Day 7, 2=mild 62.2 63.3
Day 7, 3=moderate 17.8 26.7
Day 7, 4=moderately severe 1.1 0.0
Day 7, 5=severe 0.0 0.0
Day 15, 1=none 50.0 41.1
Day 15, 2=mild 45.6 53.3
Day 15, 3=moderate 4.4 5.6
Day 15, 4=moderately severe 0.0 0.0
Day 15, 5=severe 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6920
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0749
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cyclobenzaprine HCl 15 mg, Placebo
Comments Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2371
Comments [Not Specified]
Method Wilcoxon Sum Rank Test
Comments [Not Specified]
Time Frame First dose of study drug to within 30 days of last dose of study drug (Up to 45 days)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Cyclobenzaprine HCl 15 mg Placebo
Hide Arm/Group Description Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days.
All-Cause Mortality
Cyclobenzaprine HCl 15 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/90 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cyclobenzaprine HCl 15 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/90 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cyclobenzaprine HCl 15 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/90 (23.33%)   12/90 (13.33%) 
Cardiac disorders     
Tachycardia  1  1/90 (1.11%)  0/90 (0.00%) 
Gastrointestinal disorders     
Dry mouth  1  6/90 (6.67%)  1/90 (1.11%) 
Flatulence  1  1/90 (1.11%)  2/90 (2.22%) 
Toothache  1  1/90 (1.11%)  0/90 (0.00%) 
Infections and infestations     
Influenza  1  1/90 (1.11%)  1/90 (1.11%) 
Rhinitis  1  1/90 (1.11%)  0/90 (0.00%) 
Nervous system disorders     
Dizziness  1  1/90 (1.11%)  0/90 (0.00%) 
Dysgeusia  1  1/90 (1.11%)  0/90 (0.00%) 
Headache  1  0/90 (0.00%)  1/90 (1.11%) 
Poor quality sleep  1  1/90 (1.11%)  2/90 (2.22%) 
Somnolence  1  18/90 (20.00%)  5/90 (5.56%) 
Psychiatric disorders     
Anxiety  1  1/90 (1.11%)  0/90 (0.00%) 
Disruptive mood dysregulation disorder  1  1/90 (1.11%)  0/90 (0.00%) 
Sleep disorder  1  1/90 (1.11%)  0/90 (0.00%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  0/90 (0.00%)  1/90 (1.11%) 
Rash erythematous  1  0/90 (0.00%)  1/90 (1.11%) 
Skin exfoliation  1  0/90 (0.00%)  1/90 (1.11%) 
1
Term from vocabulary, MedDRA version: 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02814565     History of Changes
Other Study ID Numbers: CYC-RR-001
U1111-1162-4846 ( Registry Identifier: WHO )
First Submitted: June 23, 2016
First Posted: June 27, 2016
Results First Submitted: January 11, 2019
Results First Posted: April 8, 2019
Last Update Posted: April 8, 2019