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.
Conditions
Interventions
Trade Name: Voltarol Emulgel P
Product Name: Voltarol Emulgel P
Pharmaceutical Form: Cutaneous emulsion
INN or Proposed INN: Diclofenac
CAS Number: 78213-16-8
Other descriptive name: Diclofenac Diethy
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is 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 endpoints: ? Time to climb stairs; ? Pain following stair climbing. ;Secondary Objective: The secondary objectives of this study are to compare the efficacy of 72 hrs treatment of topical diclofenac plus a heat patch with 72 hrs treatment of placebo gel plus a heat patch on: ? Time to climb stairs; ? Pain following stair climbing. ;Primary end point(s): ? Time to climb stairs; ? Pain following stair climbing | — |
Countries
United Kingdom
Outcome results
None listed