A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00772967

Purpose

This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents.

Condition	Intervention	Phase
Osteoarthritis	Drug: non-product or non-Merck product Drug: Comparator: Placebo Drug: Comparator: Ultracet (tramadol/acetaminophen)	Phase I

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium Tramadol hydrochloride Tramadol Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Analgesic Effects of Naproxen and Ultracet in a Walking Model of Osteoarthritis Knee Pain

Further study details as provided by Merck:

Primary Outcome Measures:

Comparison of the effects of naproxen and Ultracet to placebo using on average pain intensity during self-paced walks [ Time Frame: day 3 of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the effects of naproxen and Ultracet to placebo on average pain intensity during high pace walks, for each individual walk, at each time point, and the time to moderate or severe pain [ Time Frame: Days 1 and 3 of each treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Group 1: 3 days placebo, 3 days Naproxen, 3 days Ultracet	Drug: non-product or non-Merck product Naproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Placebo Placebo capsules twice daily on Day 1, three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Ultracet (tramadol/acetaminophen) Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
2: Experimental Group 2: 3 days naproxen, 3 days Ultracet, 3 days placebo	Drug: non-product or non-Merck product Naproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Placebo Placebo capsules twice daily on Day 1, three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Ultracet (tramadol/acetaminophen) Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
3: Experimental Group 3: 3 days Ultracet, 3 days placebo, 3 days naproxen	Drug: non-product or non-Merck product Naproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Placebo Placebo capsules twice daily on Day 1, three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Ultracet (tramadol/acetaminophen) Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
4: Experimental Group 4: 3 days placebo, 3 days Ultracet, 3 days naproxen	Drug: non-product or non-Merck product Naproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Placebo Placebo capsules twice daily on Day 1, three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Ultracet (tramadol/acetaminophen) Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
5: Experimental Group 5: 3 days naproxen, 3 days placebo, 3 days Ultracet	Drug: non-product or non-Merck product Naproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Placebo Placebo capsules twice daily on Day 1, three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Ultracet (tramadol/acetaminophen) Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
6: Experimental Group 6: 3 days Ultracet, 3 days naproxen, 3 days placebo	Drug: non-product or non-Merck product Naproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Placebo Placebo capsules twice daily on Day 1, three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. Drug: Comparator: Ultracet (tramadol/acetaminophen) Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patient has a medical/arthritic disease that would interfere with evaluation
Patient is unable to take naproxen or Ultracet
Patient has congestive heart failure or angina
Patient has a history of stroke
Patient has a history of uncontrolled high blood pressure
Patient has a history of cancer
Patient regularly uses a walker or cane

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772967

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_566, 105
Study First Received:	October 13, 2008
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00772967
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Osteoarthritis, Knee
Naproxen
Musculoskeletal Diseases
Tramadol
Osteoarthritis

Joint Diseases
Arthritis
Pain
Rheumatic Diseases
Acetaminophen

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009