Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Analgesic Solutions.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Analgesic Solutions
ClinicalTrials.gov Identifier:
NCT01557816
First received: February 21, 2012
Last updated: March 21, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Drug: Naproxen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Analgesic Solutions:

Primary Outcome Measures:
  • Efficacy of naproxen vs. placebo [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

    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

  • Safety [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

    Safety of Naproxen VS Placebo

    Safety evaluations will include:

    • Adverse events (AEs)and serious AEs (SAEs)
    • Vital signs
    • Clinical Laboratories
    • Concomitant medications


Estimated Enrollment: 70
Study Start Date: December 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naproxen Drug: Naproxen
Naproxen for 7 days (3 days at 250 mg BID followed by 4 days at 500 mg BID) during either of the 2 treatment periods.
Other Names:
  • Aleve
  • Naprosyn
Drug: Placebo
Placebo for seven days given BID during either of the 2 treatment periods.
Other Name: Sugar pill
Sham Comparator: Placebo Drug: Naproxen
Naproxen for 7 days (3 days at 250 mg BID followed by 4 days at 500 mg BID) during either of the 2 treatment periods.
Other Names:
  • Aleve
  • Naprosyn
Drug: Placebo
Placebo for seven days given BID during either of the 2 treatment periods.
Other Name: Sugar pill

Detailed Description:

This study aims to evaluate various methods of measuring pain relief in osteoarthritis (OA) of the knee. The duration of the study will be up to 5 weeks. Eligible subjects will have chronic OA of the knee. After meeting initial entry criteria and prior to randomization, there will be a 1 week wash-out from existing therapy. Subjects will then 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 a 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, nor will they be allowed to use topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication (as needed up to 2 g/day)but subjects will be told not to take acetaminophen at least 12 hours before study visits. Seventy (70) subjects will be randomized to ensure that 60 subjects complete both treatment arms.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject able to read, comprehend and sign written Informed Consent Form
  2. Subject is 21 years old or older
  3. If female, should be post-menopausal or has negative urine test
  4. Subject has some degree of target joint pain for the last 3 months
  5. 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

  6. Subject had an X-ray of the target knee showing evidence of OA within the past 3 years
  7. Target joint does not contain any type of orthopedic and/or prosthetic device
  8. Subject is ambulatory
  9. Subject is in good general medical and psychological health, and is capable of completing study assessments and procedures.

Exclusion Criteria:

  1. Subject had an x-ray of the target knee showing Kellgren-Lawrence grade 4
  2. Subject has any pain syndrome that has the potential to confound the assessment of the target knee.
  3. the subject has a documented history of an adverse reaction to NSAIDs or acetaminophen
  4. Subject is pregnant or breast feeding
  5. Subject has sitting systolic pressure > 180 mmHg or < 90mmHg, and/or a sitting diastolic pressure > 100 mmHg or < 50 mmHg at screening
  6. Subject has mass body index (BMI) > 35 kg/m2.
  7. 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
  8. 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.
  9. Subject has a clinically significant abnormalities in clinical chemistry, hematology, coagulation, or urinalysis.
  10. Subject has a significant history or renal impairment
  11. Subject has a positive urine drug screen for alcohol, illicit drugs or nonprescribed controlled substances
  12. Subject has dermatological lesions of the target knee or ipsilateral elbow at the time of screening.
  13. Subject is unable to discontinue all formulations of prior analgesics
  14. Subject has received any investigational drug within 30 days prior to screening
  15. Subject has a history of active peptic ulceration, gastrointestinal bleeding, esophageal, or gastric or duodenal ulcer within 3 months of screening
  16. Subject has had a surgical intervention for any pain within 3 months of screening or plans for surgical intervention while in the study
  17. Subject has a documented history of inflammatory arthritis, including rheumatoid arthritis.
  18. Subject has received local corticosteroid injections, viscosupplementation, or arthrocentesis in the target joint within 3 months of screening
  19. Subject has received oral or intramuscular corticosteroids within the past 30 days
  20. Subject is involved in an ongoing or settled worker's compensation claim, disability, or litigation related to any pain problem
  21. Subject had used opioids for pain more than 4 days in the week preceding screening
  22. Subject has a history of alcohol or drug abuse/dependence/misuse within 2 years of screening
  23. Subject has history of acute coronary syndrome, ischemic or hemorrhagic stroke, transient ischemic attack, or previous revascularization procedure to coronary or peripheral vasculature, or has a history of congestive heart failure within 5 years of screening
  24. Subject has had axillary lymph nodes removed bilaterally
  25. Subject has a disease-related or iatrogenic coagulopathy, or had been diagnosed with thrombocytopenia or a functional platelet disorder
  26. The subject is currently on an aromatase inhibitor.
  27. Subject has a history of any condition that, in the Investigator's opinion, precludes participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557816

Contacts
Contact: Stephen Wright, M.D. 781-444-9605 ext 101 swright@analgesicsolutions.com
Contact: Pura Requintina, Ph.D. 781-444-9605 ext 121 prequintina@analgesicsolutions.com

Locations
United States, Massachusetts
Analgesic Solutions Recruiting
Natick, Massachusetts, United States, 01760
Contact: Stephen Wright, MD    781-444-9605 ext 101    swright@analgesicsolutions.com   
Contact: Pura Requintina, Ph.D.    781-444-9605 ext 121    prequintina@analgesicsolutions.com   
Principal Investigator: Stephen Wright, MD         
Sponsors and Collaborators
Analgesic Solutions
Investigators
Principal Investigator: Stephen Wright, MD Analgesic Solutions
  More Information

No publications provided

Responsible Party: Analgesic Solutions
ClinicalTrials.gov Identifier: NCT01557816     History of Changes
Other Study ID Numbers: ALPMF-006-2010
Study First Received: February 21, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Analgesic Solutions:
osteoarthritis
knee
Naproxen

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Naproxen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014