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

NCT00772967 | Completed Phase 1 Results

• 2 other identifiers: 0000-1052008_566
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3

  Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.

  Baseline and Day 3

Secondary Outcomes (3)

• Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1

  Baseline and Day 1

• Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1

  Baseline and Day 1

• Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3

  Baseline and Day 3

Study Arms (6)

Placebo, Naproxen, Ultracet

EXPERIMENTAL

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.

Drug: Naproxen; Drug: Placebo; Drug: Ultracet

Naproxen, Ultracet, Placebo

EXPERIMENTAL

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.

Drug: Naproxen; Drug: Placebo; Drug: Ultracet

Ultracet, Placebo, Naproxen

EXPERIMENTAL

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.

Drug: Naproxen; Drug: Placebo; Drug: Ultracet

Placebo, Ultracet, Naproxen

EXPERIMENTAL

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.

Drug: Naproxen; Drug: Placebo; Drug: Ultracet

Naproxen, Placebo, Ultracet

EXPERIMENTAL

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.

Drug: Naproxen; Drug: Placebo; Drug: Ultracet

Ultracet, Naproxen, Placebo

EXPERIMENTAL

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.

Drug: Naproxen; Drug: Placebo; Drug: Ultracet

Interventions

Naproxen DRUG

Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.

Naproxen, Placebo, Ultracet; Naproxen, Ultracet, Placebo; Placebo, Naproxen, Ultracet; Placebo, Ultracet, Naproxen; Ultracet, Naproxen, Placebo; Ultracet, Placebo, Naproxen

Placebo DRUG

Placebo capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. 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.

Naproxen, Placebo, Ultracet; Naproxen, Ultracet, Placebo; Placebo, Naproxen, Ultracet; Placebo, Ultracet, Naproxen; Ultracet, Naproxen, Placebo; Ultracet, Placebo, Naproxen

Ultracet DRUG

Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. 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.

Naproxen, Placebo, Ultracet; Naproxen, Ultracet, Placebo; Placebo, Naproxen, Ultracet; Placebo, Ultracet, Naproxen; Ultracet, Naproxen, Placebo; Ultracet, Placebo, Naproxen

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6.

  PMID: 20175977 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Naproxen; Ultracet

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 20, 2015
• Results First Posted: December 5, 2012

Record last verified: 2015-10