Trials / Completed
CompletedNCT02197156
A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- Zogenix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery
Detailed description
Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 10 mg HC-ER | Single dose |
| DRUG | 20 mg HC-ER | Single dose |
| DRUG | 30 mg HC-ER | Single dose |
| DRUG | 40 mg HC-ER | Single dose |
| DRUG | 10 mg HC / 325 mg APAP | Single dose |
| DRUG | Matching Placebo | Single dose |
Timeline
- Start date
- 2002-08-01
- Primary completion
- 2003-02-01
- Completion
- 2003-02-01
- First posted
- 2014-07-22
- Last updated
- 2022-11-10
Source: ClinicalTrials.gov record NCT02197156. Inclusion in this directory is not an endorsement.