A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV)

Phase 3

Completed

• Conditions: Pain; Nausea; Vomiting
• Interventions: Drug: Placebo; Drug: CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg); Drug: Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)

• Registration Number: NCT02462811
• Lead Sponsor: Joseph Hazelton

Brief Summary

The objectives of this study are to compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the first metatarsal bone).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2016-01
• Disposition First Submitted: 2016-11-02
• Disposition First Submitted QC: 2016-11-02
• Last Update Submitted: 2016-11-02
• Disposition First Posted: 2016-11-03
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	CL-108 formulation without API
CL-108	CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)	CL-108 hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
Active Comparator: Norco	Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)	Commercial product containing hydrocodone 7.5 mg, acetaminophen 325 mg

Primary Outcome Measures

Name	Time	Method
The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours.	48 hours
The relief of moderate to severe pain, assessed by visual analog pain intensity scale, comparing CL-108 to placebo over 48 hours (SPID48).	48 hours

Secondary Outcome Measures

Name	Time	Method
The severity of opioid-induced nausea, comparing CL-108 to Norco® over 48 hours	48 hours
The occurrence of vomiting, comparing CL-108 to Norco® over 48 hours	48 hours
The use of anti-emetics, comparing CL-108 to Norco® over 48 hours.	48 hours
The relief of post-operative nausea and vomiting (PONV), comparing CL-108 to placebo over 48 hours	48 hours
Incidence of post-discharge nausea and vomiting (PDNV), comparing CL-108 to placebo over days 3-5	48 hours
The relief of severe pain, comparing CL-108 to Norco® over 48 hours, i.e., summed pain intensity differences over 48 hours (SPID48)	48 hours

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States