Phase 4
Completed N=52
The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis
Source: ClinicalTrials.gov NCT01383954 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Percent Change From Baseline in Pain Score During Week 1 — 33.3 percent change
◆ Published Evidence
Highly cited
138citations · ~14 / year
Variability in conditioned pain modulation predicts response to NSAID treatment in patients with knee osteoarthritis.
Summary
The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.
Linked Publications
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Variability in conditioned pain modulation predicts response to NSAID treatment in patients with knee osteoarthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Pain Score During Week 1 |
33.3 | — |
| PRIMARY Percent Change From Baseline in Pain Score During Week 2 |
33.3 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 20-75
- Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically.
- Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and schedule prior to the breakthrough period will be permitted.
Exclusion Criteria
- Patients with clinical history of anterior cruciate ligament (ACL) involvement.
- Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)
- History of ulcers or gastrointestinal (GI) bleeding
- Coagulation disorders
- Hypersensitivity to Aspirin or NSAIDS
- Congestive Heart Failure and Edema
- Advanced renal disease
- Aspirin triad
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT01383954) and the linked publication. 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. Informational only — not medical advice.