Back Pain, Neck Pain, Spasm
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study was to assess the effect of cyclobenzaprine hydrochloride (HCl) extended release (CER) 15 mg capsule once daily in participants with muscle spasms associated with acute painful musculoskeletal conditions.
Detailed description
The drug being tested in this study was cyclobenzaprine hydrochloride (HCl) extended-release (CER). CER was being tested to treat participants who had muscle spasms associated with acute painful musculoskeletal conditions. This study looked at medication helpfulness, relief from muscle spasms and pain, and improvement in range of motion and daily living activities. The study enrolled 180 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which remained undisclosed to the participant and study doctor during the study: * CER 15 mg * Placebo (dummy inactive pill) - this was a capsule that looks like the study drug but had no active ingredient All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in the Russian Federation. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, and were contacted by telephone after the last dose of study drug for a follow-up assessment.
Interventions
Cyclobenzaprine HCl extended-release capsules
DRUGPlacebo
Cyclobenzaprine HCl extended release placebo-matching capsules
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Is experiencing for no more than 14 days cervical or lower back pain (as assessed by the participant) due to muscle spasms (confirmed by the physician) associated with acute, painful musculoskeletal conditions. 4. Is male or female and aged 18 to 50 years, inclusive. 5. Female participants require to be either 2 years postmenopausal or surgically sterile by bilateral tubal ligation, hysterectomy, or bilateral oophorectomy, or, if premenopausal, had to be using an approved contraceptive method. 6. Female participants of child-bearing potential must have a negative urine human chorionic gonadotropin (hCG) test result for pregnancy at study entry. 7. After signing the informed consent form, the participant agrees not to make changes to dietary, exercise, or smoking habits and not to enter a weight loss program during his/her participation in the study.
Exclusion criteria
1. Has muscular pain secondary to acute trauma or fractures (e.g., due to osteoporosis). Such conditions could have been ruled out based on medical history, x-ray, or physical examination. 2. Has received any investigational compound within 30 days prior to Screening. 3. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. 4. Has a history of drug abuse or recent (within the last 12 months) history of excessive alcohol consumption defined as \>2 drinks/day (\>90 ml of 80 proof alcohol or equivalent). 5. Has mild, moderate, severe liver impairment. 6. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 7. Takes any concomitant medication including over-the-counter and herbal products for muscle spasms. If a participant is taking such medications, the medications has to be discontinued before starting the study. 8. Takes or took within last 14 days medications, such as: 1. selective serotonin reuptake inhibitors (SSRIs); 2. serotonin norepinephrine reuptake inhibitors (SNRIs); 3. tricyclic antidepressants (TCAs); 4. monoamine oxidase (MAO) inhibitors; 5. tramadol; 6. bupropion; 7. meperidine; 8. verapamil; 9. non-steroid anti-inflammatory drugs (NSAIDs); 10. topical anti-inflammatory medications 9. Has a history or clinical manifestations of significant medical condition, such as: 1. hyperthyroidism; 2. acute recovery phase of myocardial infarction; 3. arrhythmias, heart block or conduction disturbances; 4. congestive heart failure; 5. angle-closure glaucoma; 6. urinary retention; 7. increased intraocular pressure. 10. Has abnormal physical findings or a medical condition that might have placed the participant at risk or interfered with the participant's ability to participate in the study. 11. Has any known condition or disorder that might have affected absorption of the study drug. 12. Has a history of hypersensitivity or allergies to cyclobenzaprine and/or tricyclic antidepressants or any of their components. 13. Has a history of hypersensitivity to any NSAIDs including salicylate sensitivity. 14. Has a history of thrombocytopenia. 15. Has a history of gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders. 16. Had active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) 17. Has a history of severe renal impairment 18. Had a major surgery during the 6 months preceding study entry. 19. Has a language barrier or any other problems precluding good communication or cooperation. 20. Has any reason to believe that he/she would not be able to complete the evaluations needed in this study. 21. Has a known history of positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibody. 22. Drug abuse in anamnesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3 | 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. |
| Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Days 7 and 15 | 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. |
| Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Days 3, 7, and 14 | 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. |
| Percentage of Responders on Days 3, 7, and 14 of Treatment | Days 3, 7, and 14 | 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. |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Days 7 and 14 | 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. |
| Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Days 3, 7, and 15 | 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. |
| Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Days 3, 7, and 15 | 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. |
| Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Days 3, 7, and 15 | 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. |
| Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Days 3, 7, and 15 | 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. |
Countries
Russia
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Cyclobenzaprine HCl 15 mg Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. | 90 |
| Placebo Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days. | 90 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Subject decision, caused by AE Influenza | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | Cyclobenzaprine HCl 15 mg |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 9.1 | 31.5 years STANDARD_DEVIATION 9.2 | 33.0 years STANDARD_DEVIATION 9 |
| Height | 170.5 cm STANDARD_DEVIATION 8 | 169.1 cm STANDARD_DEVIATION 7.6 | 171.8 cm STANDARD_DEVIATION 8.2 |
| Race/Ethnicity, Customized European (Caucasian) | 180 Participants | 90 Participants | 90 Participants |
| Region of Enrollment Russia | 180 Participants | 90 Participants | 90 Participants |
| Sex: Female, Male Female | 110 Participants | 62 Participants | 48 Participants |
| Sex: Female, Male Male | 70 Participants | 28 Participants | 42 Participants |
| Smoking Status Current smoker | 19 Participants | 8 Participants | 11 Participants |
| Smoking Status Former smoker | 4 Participants | 3 Participants | 1 Participants |
| Smoking Status Never smoked | 157 Participants | 79 Participants | 78 Participants |
| Weight | 68.64 kg STANDARD_DEVIATION 14.25 | 66.22 kg STANDARD_DEVIATION 13.61 | 71.05 kg STANDARD_DEVIATION 14.53 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 90 |
| other Total, other adverse events | 21 / 90 | 12 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
Primary
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 1=fair | 60.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 3=very good | 3.3 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 2=good | 16.7 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 4=excellent | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 0=poor | 20.0 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 4=excellent | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 0=poor | 28.9 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 1=fair | 46.7 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 2=good | 22.2 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3, 3=very good | 2.2 percentage of participants |
Comparison: 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.p-value: 0.6179Wilcoxon Rank Sum test
Secondary
Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 1.1 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 46.7 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 18.9 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 50.0 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 2.2 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 45.6 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 62.2 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 4.4 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 46.7 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 0.0 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 17.8 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of percentage |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 4.4 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 5.6 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 50.0 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 38.9 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 5.6 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 10.0 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 63.3 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 26.7 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 0.0 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 41.1 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 53.3 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 5.6 percentage of percentage |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 0.0 percentage of percentage |
Comparison: 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.p-value: 0.692Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.0749Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.2371Wilcoxon Sum Rank Test
Secondary
Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 40.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 22.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 44.4 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 5.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 48.9 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 51.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 6.7 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 47.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 26.7 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 6.7 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 4.4 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 37.8 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 52.2 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 5.6 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 13.3 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 51.1 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 35.6 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 38.9 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 47.8 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 13.3 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 0.0 percentage of participants |
Comparison: 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.p-value: 0.5275Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.088Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.2542Wilcoxon Sum Rank Test
Secondary
Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 1.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 24.4 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 6.7 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 35.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 7.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 51.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 55.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 12.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 66.7 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 1.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 36.7 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 21.1 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 66.7 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 2.2 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 50.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 46.7 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 25.6 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 50.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 24.4 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 0.0 percentage of participants |
Comparison: 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.p-value: 0.4428Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.1163Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.0489Wilcoxon Sum Rank Test
Secondary
Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 27.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 14.4 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 48.9 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 7.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 37.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 47.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 13.3 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 62.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 37.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 2.2 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 1=none | 2.2 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 2=mild | 21.1 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 3=moderate | 66.7 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 4=moderately severe | 10.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 3, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 1=none | 5.6 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 2=mild | 53.3 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 3=moderate | 38.9 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 4=moderately severe | 2.2 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 7, 5=severe | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 1=none | 32.2 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 2=mild | 47.8 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 3=moderate | 20.0 percentage of participants |
| Placebo | Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment | Day 15, 4=moderately severe | 0.0 percentage of participants |
Comparison: 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.p-value: 0.302Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.2367Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.025Wilcoxon Sum Rank Test
Secondary
Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 2=no change | 52.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 4=moderate improvement | 11.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 3=slight improvement | 35.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 5=marked improvement | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 1=worse | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 5=marked improvement | 2.2 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 1=worse | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 2=no change | 68.9 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 3=slight improvement | 25.6 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3, 4=moderate improvement | 3.3 percentage of participants |
Comparison: 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.p-value: 0.0393Wilcoxon Sum Rank Test
Secondary
Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 1=worse | 2.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 2=no change | 8.9 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 3=slight improvement | 52.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 4=moderate improvement | 27.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 5=marked improvement | 8.9 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 1=worse | 1.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 2=no change | 5.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 3=slight improvement | 27.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 4=moderate improvement | 30.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 5=marked improvement | 35.6 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 3=slight improvement | 34.4 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 1=worse | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 1=worse | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 2=no change | 26.7 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 5=marked improvement | 21.1 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 3=slight improvement | 44.4 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 2=no change | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 4=moderate improvement | 24.4 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 15, 4=moderate improvement | 32.2 percentage of participants |
| Placebo | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Day 7, 5=marked improvement | 4.4 percentage of participants |
Comparison: 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.p-value: 0.033Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.0262Wilcoxon Sum Rank Test
Secondary
Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 5=marked improvement | 0.0 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 4=moderate improvement | 22.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 2=no change | 45.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 5=marked improvement | 7.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 1=worse | 4.4 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 1=worse | 1.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 4=moderate improvement | 3.3 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 2=no change | 14.4 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 2=no change | 13.3 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 3=slight improvement | 24.4 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 3=slight improvement | 47.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 4=moderate improvement | 27.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 3=slight improvement | 52.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 5=marked improvement | 32.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 1=worse | 3.3 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 5=marked improvement | 23.3 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 1=worse | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 2=no change | 56.7 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 3=slight improvement | 33.3 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 4=moderate improvement | 7.8 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 3, 5=marked improvement | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 1=worse | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 2=no change | 25.6 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 3=slight improvement | 43.3 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 4=moderate improvement | 25.6 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 7, 5=marked improvement | 4.4 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 1=worse | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 2=no change | 26.7 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 3=slight improvement | 20.0 percentage of participants |
| Placebo | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Day 14, 4=moderate improvement | 28.9 percentage of participants |
Comparison: 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.p-value: 0.5756Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.4395Wilcoxon Sum Rank Test
Comparison: 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.p-value: 0.0905Wilcoxon Sum Rank Test
Secondary
Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 0=poor | 7.8 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 1=fair | 41.1 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 2=good | 35.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 3=very good | 13.3 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 4=excellent | 2.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 0=poor | 8.9 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 1=fair | 25.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 2=good | 25.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 3=very good | 22.2 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 4=excellent | 17.8 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 2=good | 28.9 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 0=poor | 16.7 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 0=poor | 14.4 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 1=fair | 34.4 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 4=excellent | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 2=good | 34.4 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 1=fair | 25.6 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 3=very good | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 14, 3=very good | 20.0 percentage of participants |
| Placebo | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Day 7, 4=excellent | 3.3 percentage of participants |
Comparison: 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.p-value: 0.4338Wilcoxon Rank Sum Test
Comparison: 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.p-value: 0.1657Wilcoxon Rank Sum Test
Secondary
Percentage of Responders on Days 3, 7, and 14 of Treatment
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
Population: FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cyclobenzaprine HCl 15 mg | Percentage of Responders on Days 3, 7, and 14 of Treatment | Day 3 | 3.3 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Responders on Days 3, 7, and 14 of Treatment | Day 7 | 15.6 percentage of participants |
| Cyclobenzaprine HCl 15 mg | Percentage of Responders on Days 3, 7, and 14 of Treatment | Day 14 | 40.0 percentage of participants |
| Placebo | Percentage of Responders on Days 3, 7, and 14 of Treatment | Day 3 | 2.2 percentage of participants |
| Placebo | Percentage of Responders on Days 3, 7, and 14 of Treatment | Day 7 | 14.4 percentage of participants |
| Placebo | Percentage of Responders on Days 3, 7, and 14 of Treatment | Day 14 | 31.1 percentage of participants |
Comparison: 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.p-value: 1Fisher Exact
Comparison: 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.p-value: 1Fisher Exact
Comparison: 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.p-value: 0.2757Fisher Exact