An 8-week, multi-center, randomized, double-blind, placebo-controlled, parallel group trial of Diclofenac Sodium Gel 1% in patients with primary osteoarthritis of the hand - N/A

ovartis Consumer Health S.A.0 sites360 target enrollmentFebruary 15, 2005

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 15, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Consumer Health S.A.

Eligibility Criteria

Inclusion Criteria

•At Screening:
•The patient must:
•1\. Understand the procedures, agree to participate, and give written informed consent prior to initiation of any study procedure.
•2\. Be able to indicate right\- or left\-handedness. The dominant hand will be the target hand for the primary efficacy analysis. Both right and left\-handed subjects are included.
•3\. Have a diagnosis of primary hand OA according to ACR criteria with symptoms including pain for at least 12 months (see Post\-text supplement 1\),
•\- with a least two painful episodes in at least one finger joint during this period,
•\- reporting use of a NSAID or salicylate whether oral or topical, during at least one of these episodes, and
•\- reporting pain on \> 15 days during the preceding 30 day period.
•4\. Report that pain is usually greater in the dominant hand.
•5\. Expect to need to treat the target hand for at least 7 weeks.

Exclusion Criteria

•1\. Secondary post\-traumatic OA, history and/or evidence of any other rheumatic disease involving the potential target hand or the arm: algodystrophy, septic arthritis, inflammatory joint disease (e.g. psoriatic arthritis), rapidly destructive osteoarthropathy, chondrocalcinosis, gout, recurrent episodes of pseudogout, Paget’s disease of bone, articular fracture, ochronosis, acromegaly, hemochromatosis, primary osteochondromatosis, heritable disorders , collagen gene mutations, carpal tunnel syndrome, Dupuytren’s disease and neurological diseases of the hand or arm.
•2\. Symptomatic OA at additional locations besides the hand(s), requiring any symptomatic or disease\-modifying treatment at present or patient anticipates to require such treatment.
•3\. Radiological signs of OA Kellgren\-Lawrence grade 4 disease in the dominant hand.
•4\. Adult juvenile chronic arthritis.
•5\. History of rheumatoid arthritis or laboratory values indicative of rheumatoid arthritis with subsequent diagnosis by a physician.
•6\. History of other inflammatory diseases such as colitis within the previous year.
•7\. History of fibromyalgia within the previous year.
•8\. Laboratory values with clinically significant abnormalities. Patients with elevated ESR or CRP are excluded only if clinical signs indicate an underlying clinically significant disease and in particular if both parameters are elevated.
•9\. Females who are pregnant or lactating.
•10\. Evidence of active peptic ulceration within the previous 12 months or history of GI bleeds.