Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis

Sponsor

Nuvo Research Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00108992

Collaborator

(none)

750

Enrollment

Locations

Duration (Months)

34.1

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Diclofenac, topical	Phase 3

Detailed Description

During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical examination performed. After washout of all NSAIDs/other analgesic medication, the patient will return for the baseline visit. During the treatment phase of the study, the patient will apply a topical solution to his/her osteoarthritic knee and take an oral study tablet. The patient may randomly receive active treatment with topical diclofenac, oral diclofenac, both, or neither (placebo). Follow-up clinic visits are conducted at 4, 8 and 12 weeks. Routine laboratory analyses are done at baseline, 4 and 12 weeks.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2004

Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

pain []
physical function []
patient overall health assessment []

Secondary Outcome Measures

stiffness []
patient global assessment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary osteoarthritis of the knee, verified radiographically
Moderate flare of pain in the knee after washout of stable therapy
If female, non-pregnant
Ability to swallow moderately-sized tablets

Exclusion Criteria:

Secondary osteoarthritis of the knee
Major knee surgery at any time, or minor knee surgery in previous year
Severe uncontrolled heart, liver or kidney disease
Ulcer or bleeding from the stomach
Corticosteroid use
Fibromyalgia
Skin disorder of the knee

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research	Mobile	Alabama	United States	36608
2	Redpoint Research	Phoenix	Arizona	United States	85029
3	OMC Clinical	Beverly Hills	California	United States	90211
4	Associated Pharmaceutical Research	Buena Park	California	United States	90620
5	Med Investigators	Fair Oaks	California	United States	95628
6	Desert Medical Advances	Palm Desert	California	United States	92260
7	Boling Clinical Trials	Upland	California	United States	91786
8	Tampa Bay Medical Research Inc.	Clearwater	Florida	United States	33761
9	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
10	Medisphere Medical Research	Evansville	Indiana	United States	47714
11	Synergy Medical Education Alliance	Saginaw	Michigan	United States	48602
12	Redrock Research Center	Las Vegas	Nevada	United States	89146
13	Partners in Primary Care	Voorhees	New Jersey	United States	08043
14	Camp Hill Clinical Research Center	Camp Hill	Pennsylvania	United States	17011
15	Primary Physicians Research	Pittsburgh	Pennsylvania	United States	15241
16	University Orthopedics Center	State College	Pennsylvania	United States	16801
17	Omega Medical Research	Warwick	Rhode Island	United States	02886
18	Clinical Research Associates	Nashville	Tennessee	United States	37203
19	Research Across America	Dallas	Texas	United States	75234
20	Sam Clinical Research Center	San Antonio	Texas	United States	78229
21	Hamptom Roads Center for Clinical Research	Norfolk	Virginia	United States	23502-9921
22	National Clinical Research	Richmond	Virginia	United States	23294