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

NCT ID: NCT01557816

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-06-30

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.

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naproxen

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Placebo for seven days given BID during either of the 2 treatment periods.

Placebo

Group Type: SHAM_COMPARATOR

Naproxen

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Placebo for seven days given BID during either of the 2 treatment periods.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo for seven days given BID during either of the 2 treatment periods.

Intervention Type: DRUG

Other Intervention Names

Aleve; Naprosyn; Sugar pill

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Analgesic Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Analgesic Solutions

Locations

Analgesic Solutions

Natick, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Wright, M.D.

Role: CONTACT

swright@analgesicsolutions.com

781-444-9605 ext. 101

Pura Requintina, Ph.D.

Role: CONTACT

prequintina@analgesicsolutions.com

781-444-9605 ext. 121

Facility Contacts

Stephen Wright, MD

Role: primary

swright@analgesicsolutions.com

781-444-9605 ext. 101

Pura Requintina, Ph.D.

Role: backup

prequintina@analgesicsolutions.com

781-444-9605 ext. 121

Other Identifiers

ALPMF-006-2010

Identifier Type: -

Identifier Source: org_study_id