Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT02462850
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'dispFirstSubmitDate': '2016-11-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2015-05-22', 'dispFirstSubmitQcDate': '2016-11-02', 'studyFirstSubmitQcDate': '2015-06-02', 'dispFirstPostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': "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", 'timeFrame': '24 hours'}, {'measure': '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)', 'timeFrame': '24 hours'}, {'measure': '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).', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'keywords': ['Pain', 'Nausea', 'Vomiting'], 'conditions': ['Pain', 'Nausea', 'Vomiting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.charlestonlabs.com', 'label': 'Charleston Website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe study will also endeavor to determine\n\n* the physicians\' global evaluation of CL-108 as a treatment for moderate to severe acute pain associated with osteoarthritis of the knee or hip\n* the patients\' global impression of change in pain after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip\n* 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\n* the percentage change in pain intensity after treatment of moderate to severe acute pain associated with osteoarthritis of the knee or hip'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nInformed consent\n\n* Signed consent obtained at screening prior to any procedures being performed.\n\nGender\n\n* 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)\n\nAge\n\n* At least 18 years of age\n\nDiagnosis of OA\n\n* Clinical diagnosis of osteoarthritis of the hip and/or knee (signal joints) based on history and physical findings\n\nConfirmation of OA\n\n* 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.\\]\n\nTreatment of OA\n\n* 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).\n\nFlare of OA\n\n* Complaint of acute pain in the knee or hip (i.e., "flare" of osteoarthritis of the knee or hip)\n\nDuration of Acute Pain\n\n* Pain in the signal joint(s) with onset ≤ 14 days\n\nPain Severity\n\n* Baseline PIS score must be ≥ moderate\n\nAlcohol Intake\n\n* Willing to limit alcohol intake to ≤ 2 drinks per day during the study (i.e., from Screening Visit 1 through Follow-Up Visit 3)\n\nDiary Completion\n\n* Be willing and able to record effectiveness, tolerability, and drug utilization information in the In-Clinic and Outpatient Diaries.\n\nEXCLUSION CRITERIA\n\nMedical Condition\n\n* Presence of a serious uncontrolled medical condition (e.g., poorly controlled hypertension or diabetes)\n\nConfounding Diseases\n\n* Presence of other major joint or bone disease (e.g., gout, inflammatory arthritis, Paget\'s disease), chronic pain syndrome, or fibromyalgia\n\nSurgery\n\n* 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\n\nDrug Allergy\n\n* 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\n\nConfounding and Contraindicated Drugs\n\n* 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.\n\nInvestigational Drug Use\n\n* Use of any investigational drug within the past 30 days\n\nParticipated in Study\n\n* Previous participation in this study\n\nPregnancy, Lactation\n\n* Women who are pregnant or breast-feeding\n\nParticipant Relationship\n\n* Employee of the Principal Investigator, Sub-investigators or Charleston Laboratories or relative of an employee who is directly involved in this study.'}, 'identificationModule': {'nctId': 'NCT02462850', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Charleston Laboratories, Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CLCT-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CL-108', 'description': 'CL-108 Hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg', 'interventionNames': ['Drug: CL-108']}], 'interventions': [{'name': 'CL-108', 'type': 'DRUG', 'armGroupLabels': ['CL-108']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charleston Laboratories, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President, Regulatory Affairs', 'investigatorFullName': 'Joseph Hazelton', 'investigatorAffiliation': 'Charleston Laboratories, Inc'}}}}