NCT01557816

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Analgesic Solutions · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	Placebo	Placebo for seven days given BID during either of the 2 treatment periods.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-03-20
• Last updated: 2012-03-22

Locations

1 site across 1 country: United States