Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT02462850
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02462850
Study Brief:
Protocol Section:
NCT02462850