Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%
Primary Purpose
Knee Pain Chronic, Knee Injuries
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diclofenac Cream 8%
Diclofenac Gel 1%
Sponsored by
About this trial
This is an interventional treatment trial for Knee Pain Chronic
Eligibility Criteria
Inclusion Criteria:
- Acute and chronic knee pain, along with postoperative knee pain lasting at least two months.
Exclusion Criteria:
- Patients will be excluded if deemed inappropriate for application of topical medication therapy by the treating physician. This will include adult patients with diffuse (non-localized) pain disorders and those likely to need knee surgery during the treatment period.
- Patients with knee infection, open knee wounds, or acute knee skin lesions will be excluded.
- Patients with diclofenac or wheat or gluten allergies will also be excluded.
Sites / Locations
- Anesthesia Administration - Outcomes ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diclofenac Cream 8%
Control
Arm Description
Diclofenac Cream 8% applied 3-4 times daily for 6 weeks.
Diclofenac Gel 1% applied 3-4 times daily fr 6 weeks
Outcomes
Primary Outcome Measures
Descrete Response Scale Pain Scores
Patients will maintain a daily home pain diary. This will be recorded in the evening each day over the six week treatment period with documentation of minimum, maximum, and overall average daily pain on a 0-10/10 discrete response scale (DRS).
Secondary Outcome Measures
Full Information
NCT ID
NCT02068859
First Posted
February 18, 2014
Last Updated
February 20, 2014
Sponsor
FPR Specialty Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT02068859
Brief Title
Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%
Official Title
Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FPR Specialty Pharmacy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events. These types of oral medications are utilized by millions of Americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. In recent years, topical preparations of NSAIDs have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. For example, they are often used for knee pain. There is little systemic absorption of NSAIDs with topical administration, and consequently less likelihood of systemic side effects.
Though much less studied than oral NSAIDs, topical NSAID preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied commercially available products are diclofenac 1% compounds. Higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect.
The investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. Specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity.
One hundred six patients presenting to the Cleveland Clinic Pain Management Department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Chronic, Knee Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac Cream 8%
Arm Type
Experimental
Arm Description
Diclofenac Cream 8% applied 3-4 times daily for 6 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Diclofenac Gel 1% applied 3-4 times daily fr 6 weeks
Intervention Type
Drug
Intervention Name(s)
Diclofenac Cream 8%
Intervention Description
Subjects will be given instructions to apply the study drug topically 3-4 times daily to the affected knee. Application instructions will also be printed on the tubes of products.
Intervention Type
Drug
Intervention Name(s)
Diclofenac Gel 1%
Intervention Description
Subjects will be given instructions to apply the study drug topically 3-4 times daily to the affected knee. Application instructions will also be printed on the tubes of products.
Primary Outcome Measure Information:
Title
Descrete Response Scale Pain Scores
Description
Patients will maintain a daily home pain diary. This will be recorded in the evening each day over the six week treatment period with documentation of minimum, maximum, and overall average daily pain on a 0-10/10 discrete response scale (DRS).
Time Frame
Daily measurement for 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Acute and chronic knee pain, along with postoperative knee pain lasting at least two months.
Exclusion Criteria:
Patients will be excluded if deemed inappropriate for application of topical medication therapy by the treating physician. This will include adult patients with diffuse (non-localized) pain disorders and those likely to need knee surgery during the treatment period.
Patients with knee infection, open knee wounds, or acute knee skin lesions will be excluded.
Patients with diclofenac or wheat or gluten allergies will also be excluded.
Facility Information:
Facility Name
Anesthesia Administration - Outcomes Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Johnson
Phone
216-444-9950
Email
johnsor13@ccf.org
First Name & Middle Initial & Last Name & Degree
Daniel J Leizman, MD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%
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