Status:
COMPLETED
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Pain
Osteoarthritis, Hip
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthr...
Detailed Description
In this clinical trial subjects are enrolled, who are suffering from pain due to osteoarthritis of the hip or the knee that is not sufficiently controlled with either a non steroidal anti-inflammatory...
Eligibility Criteria
Inclusion
- Documented Osteoarthritis of the hip or knee
- Chronic pain for more than 3 months treated with daily analgesic for the last month
- Moderate to severe OA pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol
- Moderate to severe pain by means of a mean weekly score of \>= 5 in the Brief Pain Invetory item 5 'pain on average'
Exclusion
- Regular treatment with an opioid in the 4 weeks before screening visit (infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable, however, treatment must be stopped at screening visit)
- Diagnosis of major depression
- Treatment for epilepsy
- Corticosteroid injection within the last 3 months
- Major surgery in the 3 months before the start of the study
- Women who are pregnant or breast-feeding
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00980798
Start Date
October 1 2007
End Date
November 1 2008
Last Update
April 25 2014
Active Locations (12)
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1
Klatovy, Czechia
2
Olomouc, Czechia
3
Pelhøimov, Czechia
4
Prague, Czechia