Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain

Phase 3

Completed

• Conditions: Pain, Postoperative; Bunion
• Interventions: Drug: placebo; Drug: COV155

• Registration Number: NCT01743625
• Lead Sponsor: Mallinckrodt

Brief Summary

The purpose of this study is to show the effectiveness of COV155 compared to placebo in subjects with acute moderate to severe pain following bunionectomy surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Disposition First Submitted: 2014-10-10
• Disposition First Submitted QC: 2014-10-10
• Disposition First Posted: 2014-10-20
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matching tablet to COV155 without containing active ingredients, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.
COV155	COV155	COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.

Primary Outcome Measures

Name	Time	Method
SPID48 (Summed pain intensity difference)	48 hours	48 hour Summed pain intensity difference

Secondary Outcome Measures

Name	Time	Method
Analgesic effects of COV155 versus placebo	48 hours	Pain intensity scores, pain intensity differences, and summed pain intensity differences; pain relief scores and total pain relief; percent responders; mean dosing interval; use of rescue medication; global assessment of subject satisfaction with study treatment.
Safety and tolerability of COV155	48 hours	Safety and tolerability to be evaluated with physical exams, vital signs, pulse oximetry, clinical laboratory tests, electrocardiograms, and adverse events
Onset of analgesia of COV155 versus placebo	48 hours	Onset of confirmed perceptible pain relief, time to meaningful pain relief, and time to peak pain intensity difference

Trial Locations

Locations (5)

Lotus Clinical Research, LLC; 🇺🇸 Pasadena, California, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Endeavor Clinical Trails, PA; 🇺🇸 San Antonio, Texas, United States

Chesapeake Research Group, LLC; 🇺🇸 Pasadena, Maryland, United States

Jean Brown Research, Inc.; 🇺🇸 Salt Lake City, Utah, United States