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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

Primary Purpose

Pain, Nausea, Vomiting

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CL-108
Sponsored by
Charleston Laboratories, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Nausea, Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CL-108

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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)
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).

Full Information

First Posted
May 22, 2015
Last Updated
November 2, 2016
Sponsor
Charleston Laboratories, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02462850
Brief Title
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
Official Title
A Phase 3 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charleston Laboratories, Inc

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Nausea, Vomiting
Keywords
Pain, Nausea, Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CL-108
Arm Type
Experimental
Arm Description
CL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
Intervention Type
Drug
Intervention Name(s)
CL-108
Primary Outcome Measure Information:
Title
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
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
Time Frame
24 hours
Title
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)
Time Frame
24 hours
Title
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).
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.charlestonlabs.com
Description
Charleston Website

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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

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