A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV
Summary
To determine the analgesic efficacy of CL-108 5 mg by comparison with placebo and the anti-emetic efficacy of CL-108 5 mg by comparison with hydrocodone 5 mg/acetaminophen 325 mg.
Timeline
- Start
- 2017-08-02
- Primary completion
- 2018-04-16
- Completion
- 2018-11-30
Outcome
Mixed primary results
registry COUNT_OF_PARTICIPANTS CL-108: 8 Participants NCT03657810 ↗
registry COUNT_OF_PARTICIPANTS Norco: 31 Participants NCT03657810 ↗
registry analysis (superiority test); CL-108 vs Norco; p <0.001; Regression, Logistic; NCT03657810 ↗
registry MEAN CL-108: 108.5 (Standard Deviation 80.66) score on a scale NCT03657810 ↗
registry MEAN Norco: 94.8 (Standard Deviation 69.53) score on a scale NCT03657810 ↗
registry analysis (superiority test); CL-108 vs Norco; p = 0.052; Regression, Logistic; NCT03657810 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | — |
| Subject | Hydrocodone | Unknown | 5 mg | — |
| Subject | Promethazine | Small molecule | 12.5 mg | — |
Indications
No indication recorded.