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Clinical Trials/EUCTR2007-005082-34-GB
EUCTR2007-005082-34-GBActive, not recruitingNot Applicable

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 Combination

GlaxoSmithKline Consumer Healthcare0 sitesStarted: October 16, 2007Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •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.
  • •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.

Investigators

Sponsor
GlaxoSmithKline Consumer Healthcare

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