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

Charleston Laboratories

Status and phase

Completed

Phase 3

Conditions

Vomiting

Nausea

Pain

Treatments

Drug: CL-108

Study type

Interventional

Funder types

Industry

Identifiers

NCT02462850

CLCT-006

Details and patient eligibility

About

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.

Full description

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

Enrollment

178 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

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

Pain in the signal joint(s) with onset ≤ 14 days

Pain Severity

Baseline PIS score must be ≥ moderate

Alcohol Intake

Willing to limit alcohol intake to ≤ 2 drinks per day during the study (i.e., from Screening Visit 1 through Follow-Up Visit 3)

Diary Completion

Be willing and able to record effectiveness, tolerability, and drug utilization information in the In-Clinic and Outpatient Diaries.

EXCLUSION CRITERIA

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

Women who are pregnant or breast-feeding

Participant Relationship

Employee of the Principal Investigator, Sub-investigators or Charleston Laboratories or relative of an employee who is directly involved in this study.