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A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery

NCT02197156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2022-11-10

No results posted yet for this study

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

Conditions

  • Postoperative Pain

Interventions

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

Sponsors & Collaborators

  • Zogenix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2003-02-28
Completion
2003-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02197156 on ClinicalTrials.gov