A Proof of Principle Study to Investigate the Efficacy of aMedical Device and Topical Analgesic Combination for theTreatment of Pain and Performance Related Function inOsteoarthritis - PoP for Device and Analgesic Combinatio

• Conditions: To compare the efficacy of 72 hours (hrs) treatment of topical diclofenac plus a heat patch with 72 hrs treatment of topical diclofenac plus a placebo patch on the primary endpoint of mobility in presence of OA inflammation.

• Registration Number: EUCTR2007-005082-34-GB
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Age
Aged at least 50 years.
2)Diagnosis
a) Has a radiological diagnosis of OA affecting at least one knee.
b) Has symptomatic OA of at least one knee. The symptoms should be significantly worse in one knee than the other if OA affects both knees.
c) When questioned at the screening visit, confirm they experience at least mild pain when climbing stairs.
d) Able to walk unaided or with the aid of one stick (2 sticks not allowed).
3)Contraception
Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
4)Compliance
Understands and is willing, able and likely to comply with all study procedures and restrictions.
5)Consent
Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
6)General Health
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history, physical examination or clinical laboratory test.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Pregnancy
Women who are pregnant or who have a positive urine pregnancy test.
2)Breast-feeding
Women who are breast–feeding.
3)Medical History
a) Suffer from any other condition that would affect their ability to rate pain, complete the exercises or refrain from treatment.
b) Are unable to clearly differentiate between symptoms in the joint under investigation compared to the opposite knee.
c) Have a history or current evidence of the following secondary causes of OA: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility) or collagen gene mutations.
d) Have any specific contraindications to the use of heat patches including inability to feel heat (e.g. neuropathies, circulatory problems) or have damaged skin (scratch, burn, sunburn etc.).
e) Have asthma, urticaria, or acute rhinitis which is precipitated by aspirin or other NSAIDs.
f) Have any skin conditions (e.g. eczema) that might interfere with the use of the patch for a three day period.
g) Have had a knee replacement (in the knee to be treated).
4)Medications
Patients who have started taking glucosamine supplements within the 6 months prior to the start of the study.
5)Allergy/Intolerance
Known or suspected intolerance or hypersensitivity to the study materials, washout medication (or closely related compounds) or any of their stated ingredients.
6)Clinical Study/Experimental Medication
a)Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
b)Previous participation in this study.
7)Substance abuse
Recent history (within the last year) of alcohol or other substance abuse.
8)Personnel
An employee of the sponsor or the study site or an immediate family member, or resident at the same address as another patient in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified