Status:
TERMINATED
Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis
Lead Sponsor:
University of Southampton
Collaborating Sponsors:
Pascoe Pharmazeutische Praeparate GmbH
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3% and 6% of the Cauca...
Detailed Description
STUDY DESIGN: Randomized, placebo-controlled, dose-ranging two-centre study PREPARATIONS FOR INVESTIGATION: Devil's Claw (Allya®)/placebo as tablets STATISTICAL METHODS: Analysis on an intention to ...
Eligibility Criteria
Inclusion
- Patients with either a pragmatic diagnosis of osteoarthritis of the knee, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for knee OA1):
- knee pain on most days of the previous month
- morning stiffness of less than 30 minutes duration
- "stiffness" in resting the joint and and are aged over 40 years
- osteoarthritis of the hip, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for hip OA2):
- hip pain on most days of the previous month and at least two of the following 3 features:
- ESR \< 20mm/hour
- Radiographic femoral or acetabular osteophytes
- Radiographic joint space narrowing (superior, axial and/or medial)
- And are aged over 45 years of age
- The diagnosis of osteoarthritis will be confirmed by X-ray. Only patients who have grade 2 to 4 of the Kellgren and Lawrence scale will be recruited. (The Kellgren and Lawrence scale ranges from grade 0 to grade 4 where grades 0 and 1 represent doubtful osteoarthritic changes and therefore a doubtful diagnosis.)
- Patients who have been on stable medication (conventional or complementary, including nutritional medicine) for the past three months, but are still getting symptoms (incomplete responders)
- Only those patients who record baseline pain scores on the WOMAC scale of at least 20 mm on the VAS for a minimum of 6 out of 7 days monitored during the period from Clinic Visit 1 (screening) and Clinic Visit 2 (baseline)
- Ability to comply with the requirements of the study and to give informed consent
- For women of child-bearing potential: negative pregnancy test
Exclusion
- Participation in an investigational trial within 30 days prior to enrollment
- Previous treatment with Devil' s Claw within 90 days prior to enrollment
- Patients awaiting a replacement knee or hip joint
- Patients with other conditions that cause pain
- Patients with congenital dislocation of the hip
- Patients who have had operations on their hip due to previous trauma
- Patients with severe co-morbidities - including severe cardiac or pulmonary disease and cancer
- Dementia, psychoses, or other significant impairment of mental status that would prohibit sufficient comprehension, provision of informed consent and to allow undertaking of the necessary self-care or toxicity reporting
- Patients taking corticosteroid medication
- Known allergies against any of the ingredients of the treatments
- Patients who would be unable to complete the self assessment forms, or to attend for X-ray and clinical examination
- Patients with other known rheumatic disease such as rheumatoid arthritis
- Patients with the diagnosis gout
- Patients who report a red or hot swollen joint (which is unlikely to be due to OA), and would require further rheumatological assessment
- Patients with conditions known to be contraindicated to the study medication i.e. patients with gastric or duodenal ulcers; gallstones; patients taking drugs for arrhythmias; patients with heart failure
- Patients who are pregnant, trying to become pregnant or breastfeeding
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00295490
Start Date
December 1 2004
End Date
June 1 2008
Last Update
September 12 2011
Active Locations (1)
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1
Wellcome Trust Clinical Research Facility, Southampton General Hospital
Southampton, Hants, United Kingdom, SO16 6YD