A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: Placebo; Drug: Ultracet; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772967

2008_566 (Other Identifier)

0000-105

Details and patient eligibility

About

This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.

Enrollment: 22 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has osteoarthritis of the knee and primary source of pain is knee
• Females must not be pregnant or nursing and must agree to use birth control throughout the study
• Is willing to limit alcohol and caffeine intake
• Is willing to abstain from smoking during study visits
• Must be able to walk on a treadmill at a pace of at least 1 mile/hour

Exclusion criteria

• Has a medical/arthritic disease that would interfere with evaluation
• Is unable to take naproxen or Ultracet
• Has congestive heart failure or angina
• Has a history of stroke
• Has a history of uncontrolled high blood pressure
• Has a history of cancer
• Regularly uses a walker or cane

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 6 patient groups

Placebo, Naproxen, Ultracet

Experimental group

Description:

Participants were treated with Placebo for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.

Treatment:

Drug: Placebo

Drug: Naproxen

Drug: Ultracet

Naproxen, Ultracet, Placebo

Experimental group

Description:

Participants were treated with Naproxen for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.

Treatment:

Drug: Placebo

Drug: Naproxen

Drug: Ultracet

Ultracet, Placebo, Naproxen

Experimental group

Description:

Participants were treated with Ultracet for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.

Treatment:

Drug: Placebo

Drug: Naproxen

Drug: Ultracet

Placebo, Ultracet, Naproxen

Experimental group

Description:

Participants were treated with Placebo for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.

Treatment:

Drug: Placebo

Drug: Naproxen

Drug: Ultracet

Naproxen, Placebo, Ultracet

Experimental group

Description:

Participants were treated with Naproxen for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.

Treatment:

Drug: Placebo

Drug: Naproxen

Drug: Ultracet

Ultracet, Naproxen, Placebo

Experimental group

Description:

Participants were treated with Ultracet for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.

Treatment:

Drug: Placebo

Drug: Naproxen

Drug: Ultracet