Phase 1
N=22
A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00772967 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: 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 — -0.927; -1.54; -1.73 units on a scale — p=0.089
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Naproxen (Drug); Placebo (Drug); Ultracet (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-0.927; -1.54; -1.73 | 0.089 |
| SECONDARY 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 |
-0.438; -0.956; -1.47 | 0.048 sig |
| SECONDARY 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 |
0.150; -0.508; -1.00 | 0.052 |
| SECONDARY 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 |
-0.234; -1.11; -1.30 | 0.019 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00772967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.