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| Sponsor: | Norpharma A/S |
|---|---|
| Collaborator: |
Mundipharma Finland |
| Information provided by: | Norpharma A/S |
| ClinicalTrials.gov Identifier: | NCT00426647 |
Purpose
The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.
The secondary objectives are to evaluate the safety and general satisfaction for the patients in the two treatment groups.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Pain |
Drug: Buprenorphine Drug: Tramadol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised Double-blind Multicentre Equivalence Study With Active Parallel Comparator Group to Evaluate the Efficacy and Safety of Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip, Knee &/or Lumbar Spine. |
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Buprenorphine
Norspan transdermal patch
|
Drug: Buprenorphine |
|
Active Comparator: Tramadol
Tramadol SR tablets
|
Drug: Tramadol |
This is a randomised, double-blind, multicentre equivalence study with active comparator, parallel group, to evaluate the efficacy and safety of Norspan® patches versus Tramadol in subjects with OA pain in hip, knee and/or lumbar spine, currently receiving sub-optimal analgesic treatment (defined as BS-11 score > 4) when treated with paracetamol 4000 mg/day or another analgesic at least comparable to this.
The study consist of 4 phases:
Run-in, Wash-out, Double blind and Follow-up
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males and females aged 18 years or more (women of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, contraceptive pill or depot gestagen) throughout the study) with osteoarthritis in the hip &/or knee.
Or Males & females aged 50 years or more with osteoarthritis in lumbar spine without nerve root pressure.
Clinical diagnosis of OA in the hip and/or knee including fulfilment of ACR-criteria and radiographic or MR-Scan evidence for the primary OA-joint in hip &/or knee.
Or Clinical diagnosis of OA in the lumbar spine without nerve root pressure, & with radiographic or CT-scan evidence for lumbar OA.
Exclusion Criteria:
Contacts and Locations| Finland | |
| Dr. Olavi Airaksinen | |
| Oma Lääkäri Oy, Vuorikatu 20, Kuopio, Finland, FIN-70100 | |
| Study Director: | Dorthe Tvinnemose, DVM | Norpharma A/S, Slotsmarken 15, DK-2970 Hoersholm, Denmark |
| Principal Investigator: | Kim H Kristiansen, DM | GP, Noerretorv 10, DK-7200 Grindsted, Denmark |
| Principal Investigator: | Olavi Airaksinen, DM | Oma Lääkäri Oy, Vuorikatu 20, FIN-70100 KUOPIO |
More Information
| ClinicalTrials.gov Identifier: | NCT00426647 History of Changes |
| Other Study ID Numbers: | BUP4006, NORTOP |
| Study First Received: | January 23, 2007 |
| Last Updated: | January 29, 2010 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency; Finland: Ethics Committee; Finland: Finnish Medicines Agency |
|
Osteoarthritis Pain Norspan Buprenorphine Tramadol |
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Buprenorphine Tramadol Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |