Clinical trial NCT01383954: The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis
Official title: The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2011-06-28
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

Detailed description: The purpose of this proposed study is to conduct a trial with knee OA patients using the diclofenac gel. The effectiveness of diclofenac gel in managing breakthrough pain or the neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or allodynic components) in knee OA is unknown. It is likely that patients will use the gel in a as needed (prn) fashion, on top of other analgesics prescribed for their pain. The neuropathic components of a generally nociceptive or inflammatory condition, such as knee OA, are underappreciated, and typically not tracked in OA analgesic studies. Yet, evidence across a variety of chronic painful conditions suggests that these components are quite disabling. The results of this study would show whether diclofenac gel as a prn medication is beneficial to patients suffering from knee OA pain.

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

Primary outcomes:
measure: Percent Change From Baseline in Pain Score During Week 1
timeFrame: Baseline and Week 1
measure: Percent Change From Baseline in Pain Score During Week 2
timeFrame: Baseline and Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Ajay D Wasan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edwards RR, Dolman AJ, Martel MO, Finan PH, Lazaridou A, Cornelius M, Wasan AD. Variability in conditioned pain modulation predicts response to NSAID treatment in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2016 Jul 13;17:284. doi: 10.1186/s12891-016-1124-6.