At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 349 enrolled
Drug / intervention
CL-108 5 mg +2 moredrug
Likely dose
CL-108 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Moderate-to-Severe Acute Pain and the Prevention of Opioid-Induced Nausea and Vomiting (OINV) Following Orthopedic Surgery
In Brief
A Phase 3 clinical trial evaluating CL-108 5 mg, Norco, and 1 other intervention for Pain and 2 related conditions. Completed, enrolled 349 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
Primary CompletionApr 2018
First PostedSep 2018
Study CompletionNov 2018
TodayJul 2026
First PostedSep 5, 2018
Enrollment StartAug 2, 2017
Primary CompletionApr 16, 2018
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.8 years ago
Interventions
CL-108 5 mgdrug
hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg
Norcodrug
hydrocodone 5 mg/APAP 325 mg
Placebodrug
Placebo matching CL-108