The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383954
• Other study ID #: 2009p000667
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2011
• Last updated: April 26, 2013
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ages 20-75

• Unilateral or bilateral knee OA, confirmed radiographically.

• Patients taking oral NSAIDs in the amount and schedule prior to the breakthrough period will be permitted.

Exclusion Criteria:

• Patients with clinical history of ACL involvement.

• Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)

• History of ulcers or GI bleeding

• Coagulation disorders

• Hypersensitivity to Aspirin or NSAIDS

• Congestive Heart Failure and Edema

• Advanced renal disease

• Aspirin triad

• Pregnant women

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breakthrough Pain
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Voltaren
All subjects will be prescribed diclofenac gel: 4 grams applied QID to the affected knee. Subjects will take a maximum dosage of 32g/day

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent improvement in pain	The primary outcome measure is the percent improvement in pain (prior to gel-1 hour after gel) after each diclofenac gel application for breakthrough pain. This is calculated from the pain ratings input into the ED just prior to and after gel application. Sample size calculations use a power of .85, an alpha level of .05, a pre-gel pain level of ~7/10, a standard deviation of response of 1.6, and T test comparisons. We estimate that 30 subjects will be needed to find a 30% improvement in breakthrough pain on average in the cohort.	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	No