Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
A Randomized, Double-Blind, Placebo-controlled Cross-over, Exploratory Trial of Naproxen to Evaluate Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
1 other identifier
interventional
70
1 country
1
Brief Summary
This study aims to evaluate various methods of measuring pain relief in subjects who have chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment, subjects will have another week of wash-out followed by a second period of 1 week of the alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory drugs (NSAIDs) or other oral analgesics, or topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 22, 2012
February 1, 2012
6 months
February 21, 2012
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy of naproxen vs. placebo
Efficacy of naproxen VS placebo will be analyzed by efficacy end-points of within-subject difference. Efficacy evaluations will include: * In-clinic pain intensity NRS (24-hour recall) * WOMAC: pain subscale, stiffness subscale, function subscale, and total scores * Daily actiwatch pain intensity * In-clinic pain intensity NRS for curent pain at rest and after exercise * Thermal pain matching at rest and after exercise * PGIC (Patient's Global Impression of Change) * Subject treatment reference
5 weeks
Safety
Safety of Naproxen VS Placebo Safety evaluations will include: * Adverse events (AEs)and serious AEs (SAEs) * Vital signs * Clinical Laboratories * Concomitant medications
5 weeks
Study Arms (2)
Naproxen
ACTIVE COMPARATORPlacebo
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subject able to read, comprehend and sign written Informed Consent Form
- Subject is 21 years old or older
- If female, should be post-menopausal or has negative urine test
- Subject has some degree of target joint pain for the last 3 months
- Subject has to have 3 out of six:
- ( )Age \> 50 ( )Morning stiffness \< 30 minutes ( )Crepitus on active motion ( )Bony enlargement ( )No palpable warmth of synovium
- Subject had an X-ray of the target knee showing evidence of OA within the past 3 years
- Target joint does not contain any type of orthopedic and/or prosthetic device
- Subject is ambulatory
- Subject is in good general medical and psychological health, and is capable of completing study assessments and procedures.
You may not qualify if:
- Subject had an x-ray of the target knee showing Kellgren-Lawrence grade 4
- Subject has any pain syndrome that has the potential to confound the assessment of the target knee.
- the subject has a documented history of an adverse reaction to NSAIDs or acetaminophen
- Subject is pregnant or breast feeding
- Subject has sitting systolic pressure \> 180 mmHg or \< 90mmHg, and/or a sitting diastolic pressure \> 100 mmHg or \< 50 mmHg at screening
- Subject has mass body index (BMI) \> 35 kg/m2.
- Subject has a Hospital Anxiety and Depression Scale (HADS) score \> 12 on either subscale or has an established history of major depressive disorder not controlled with medication
- Subject has had an introduction of physiotherapy, acupuncture, or transcutaneous electrical nerve stimulation within 4 weeks before screening, or has no stable regimen of these modalities.
- Subject has a clinically significant abnormalities in clinical chemistry, hematology, coagulation, or urinalysis.
- Subject has a significant history or renal impairment
- Subject has a positive urine drug screen for alcohol, illicit drugs or nonprescribed controlled substances
- Subject has dermatological lesions of the target knee or ipsilateral elbow at the time of screening.
- Subject is unable to discontinue all formulations of prior analgesics
- Subject has received any investigational drug within 30 days prior to screening
- Subject has a history of active peptic ulceration, gastrointestinal bleeding, esophageal, or gastric or duodenal ulcer within 3 months of screening
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Analgesic Solutions
Natick, Massachusetts, 01760, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Wright, MD
Analgesic Solutions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2012
First Posted
March 20, 2012
Study Start
December 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 22, 2012
Record last verified: 2012-02