search
Back to results

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
FPR Specialty Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Pain Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
February 18, 2014
Last Updated
February 20, 2014
Sponsor
FPR Specialty Pharmacy
search

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%

We'll reach out to this number within 24 hrs