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

NCT02462850 | Completed Phase 3

• 1 other identifier: CLCT-006
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Nausea; Vomiting

Keywords

Pain; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

Study Arms (1)

CL-108

EXPERIMENTAL

CL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg

Drug: CL-108

Interventions

CL-108 DRUG

CL-108

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Signed consent obtained at screening prior to any procedures being performed.
• Gender
• Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is post-menopausal or using an acceptable method of birth control (i.e., hormonal, transdermal, or implanted contraceptives, intra-uterine device, diaphragm, condom, abstinence, or surgical sterilization)
• Age
• At least 18 years of age
• Diagnosis of OA
• Clinical diagnosis of osteoarthritis of the hip and/or knee (signal joints) based on history and physical findings
• Confirmation of OA
• Radiographic evidence of OA of the knee or hip (e.g., joint space narrowing, K-L grades 1-4). \[Any X-ray finding or report of an X-ray finding at any time that is indicative of OA of the knee or hip confirms the diagnosis of OA.\]
• Treatment of OA
• Inadequate or unsatisfactory treatment with an NSAID for OA of the knee or hip with no previous use of an opioid for OA (i.e., need for "step up" to opioid treatment).
• Flare of OA
• Complaint of acute pain in the knee or hip (i.e., "flare" of osteoarthritis of the knee or hip)
• Duration of Acute Pain

You may not qualify if:

• Medical Condition
• Presence of a serious uncontrolled medical condition (e.g., poorly controlled hypertension or diabetes)
• Confounding Diseases
• Presence of other major joint or bone disease (e.g., gout, inflammatory arthritis, Paget's disease), chronic pain syndrome, or fibromyalgia
• Surgery
• Patients who have had surgery on the affected joint within the past 6 months, subjects with a prosthesis at the index joint, patients possibly requiring knee or hip arthroplasty or other surgical procedure on the index joint within 3 months following screening
• Drug Allergy
• History of hypersensitivity to an opioid drug, promethazine, acetaminophen, or NSAID (such as ibuprofen) or history of a dystonic/dyskinetic reaction to prior antiemetic or anti-psychotic medication
• Confounding and Contraindicated Drugs
• Use within 24 hours of Visit 2 of any analgesic (in particular, opioid), anti-emetic, glucosamine, chondroitin sulfate, or any drug contraindicated with hydrocodone, acetaminophen, or promethazine. Use within 4 months of Visit 2 of any intra-articular or oral corticosteroid or hyaluronic acid.
• Investigational Drug Use
• Use of any investigational drug within the past 30 days
• Participated in Study
• Previous participation in this study
• Pregnancy, Lactation

Sponsors & Collaborators

• Charleston Laboratories, Inc: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Charleston Website

MeSH Terms

Conditions

Pain; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Regulatory Affairs

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 4, 2015
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 3, 2016

Record last verified: 2016-02

Locations

US (1)