Trial · NCT02814565
Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
NCT02814565, Phase 3, Completed, Takeda; results first posted 2019-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin. Trials, record NCT02814565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02814565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin
- NCT number
- NCT02814565
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 180 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Neck Pain, Back Pain, Spasm
- Interventions
- Cyclobenzaprine HCl, Placebo
- First posted
- 2016-06-27
- Last updated
- 2019-04-08
- Results first posted
- 2019-04-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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". |
| Secondary | 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". |
| Secondary | 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". |
| Secondary | 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". |
| Secondary | 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. |
| Secondary | 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". |
| Secondary | 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". |
| Secondary | 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". |
| Secondary | 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". |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Day 3 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment | Days 7 and 14 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment | Day 3 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment | Days 7 and 15 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment | Days 3, 7, and 14 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders on Days 3, 7, and 14 of Treatment | Days 3, 7, and 14 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | 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 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | 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 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | 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 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of participants | NUMBER |
| SECONDARY | 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 | FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment. | percentage of percentage | NUMBER |
Source ClinicalTrials.gov
Results by group216
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Cyclobenzaprine HCl 15 mg | Day 3, 0=poor | 20.0 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Placebo | Day 3, 0=poor | 28.9 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Cyclobenzaprine HCl 15 mg | Day 3, 1=fair | 60.0 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Placebo | Day 3, 1=fair | 46.7 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Cyclobenzaprine HCl 15 mg | Day 3, 2=good | 16.7 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Placebo | Day 3, 2=good | 22.2 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Cyclobenzaprine HCl 15 mg | Day 3, 3=very good | 3.3 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Placebo | Day 3, 3=very good | 2.2 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Cyclobenzaprine HCl 15 mg | Day 3, 4=excellent | 0.0 | percentage of participants | |
| Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment | Placebo | Day 3, 4=excellent | 0.0 | percentage of participants |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cyclobenzaprine HCl 15 mg | 90 | |
| Overall Study | STARTED | Placebo | 90 | |
| Overall Study | COMPLETED | Cyclobenzaprine HCl 15 mg | 89 | |
| Overall Study | COMPLETED | Placebo | 88 | |
| Overall Study | NOT COMPLETED | Cyclobenzaprine HCl 15 mg | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | Cyclobenzaprine HCl 15 mg | 1 | 90 | |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 90 | |
| other | Dry mouth | Gastrointestinal disorders | Cyclobenzaprine HCl 15 mg | 6 | 90 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 90 | |
| other | Flatulence | Gastrointestinal disorders | Cyclobenzaprine HCl 15 mg | 1 | 90 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 2 | 90 | |
| other | Toothache | Gastrointestinal disorders | Cyclobenzaprine HCl 15 mg | 1 | 90 | |
| other | Toothache | Gastrointestinal disorders | Placebo | 0 | 90 | |
| other | Influenza | Infections and infestations | Cyclobenzaprine HCl 15 mg | 1 | 90 | |
| other | Influenza | Infections and infestations | Placebo | 1 | 90 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cyclobenzaprine HCl 15 mg | 0 | 90 |
| Total, all-cause mortality | Placebo | 0 | 90 |
| Total, other adverse events | Cyclobenzaprine HCl 15 mg | 21 | 90 |
| Total, other adverse events | Placebo | 12 | 90 |
| Total, serious adverse events | Cyclobenzaprine HCl 15 mg | 0 | 90 |
| Total, serious adverse events | Placebo | 0 | 90 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cyclobenzaprine HCl 15 mg vs Placebo: deaths from any cause | Trial comparisons |
| Cyclobenzaprine HCl 15 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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