Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 180 | — | — | Oct 12, 2016 | Mar 14, 2017 | Apr 8, 2019 | 10 | Russia |
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".
| Arm | Type | Description |
|---|---|---|
| Cyclobenzaprine HCl 15 mg | EXPERIMENTAL | Cyclobenzaprine Hydrochloride (HCl) extended-release, 15 mg capsules, orally, once daily for 14 days. |
| Placebo | PLACEBO_COMPARATOR | Cyclobenzaprine HCl extended release placebo-matching capsules, orally, once daily for 14 days. |
| Name | Type | Description |
|---|---|---|
| Cyclobenzaprine HCl | DRUG | Cyclobenzaprine HCl extended-release capsules |
| Placebo | DRUG | Cyclobenzaprine HCl extended release placebo-matching capsules |
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 experien...