A Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Phase 3

Completed

• Conditions: Nausea; Vomiting; Pain
• Interventions: Drug: CL-108

• Registration Number: NCT02462850
• Lead Sponsor: Charleston Laboratories, Inc

Brief Summary

The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.

Detailed Description

The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.

The study will also endeavor to determine

* the physicians' global evaluation of CL-108 as a treatment for moderate to severe acute pain associated with osteoarthritis of the knee or hip

* the patients' global impression of change in pain after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip

* any change in the patient's quality of life after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip

* the percentage change in pain intensity after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Status Verified: 2016-02
• 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: 178

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CL-108	CL-108	CL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg

Primary Outcome Measures

Name	Time	Method
The safety of CL-108 will be evaluated and assessed by questionnaire, when used, for the treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip.	24 hours

Secondary Outcome Measures

Name	Time	Method
The change in arthritic pain since taking study medication over a specific period will be assessed on the Patient Global Impression of Change scale (PGIC)	24 hours
Patients will complete a standard QOL questionnaire, comprising five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression).	24 hours
An assessment of the study medication will be provided as a treatment for osteoarthritis on the Physician's Global Evaluation (PGE) utilizing a poor to excellent scale	24 hours

Trial Locations

Locations (1)

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