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Norspan Efficacy and Safety Among Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma AB
ClinicalTrials.gov Identifier:
NCT01276431
First received: January 10, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee.


Condition Intervention Phase
Osteoarthritis Pain of the Hip and or Knee
 Drug: Buprenorphine transdermal patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Mundipharma AB:

Primary Outcome Measures:
  • Box Scale-11 (BS-11) pain scores (pain on average during the last seven days, mean change from Baseline to Completion (fulfilled all visits in the study). [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario & McMaster Universities OA Index [ Designated as safety issue: No ]
  • European QOL Health Questionnaire [ Designated as safety issue: No ]
  • Sleep disturbance & quality of sleep questions [ Designated as safety issue: No ]
  • Patients global assessment of pain relief [ Designated as safety issue: No ]
  • Investigators global assessment of pain relief [ Designated as safety issue: No ]
  • Incidence of rescue medication [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Buprenorphine transdermal patch
For two age groups: 50-60 years and >= 75 years of age
 Drug: Buprenorphine transdermal patch

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Summary Criteria for Inclusion:

  1. Males and females aged 50-60 or ≥ 75 years.
  2. Subjects with clinical diagnosis of osteoarthritis in knee and/or hip including fulfilment of ACR-criteria and radiographic evidence not older than one year.
  3. Subjects with a moderate to severe pain, confirmed by a BS-11 score ≥ 4 for their pain on average during the last seven days of the Screening Phase in their primary OA-site at the Baseline Visit.

Summary Criteria for Exclusion:

  1. Subjects recording < 4 on average during the Screening Phase on the BS-11 scale.
  2. Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine) for their osteoarthritis pain.
  3. Subjects treated with a regular dose for > 1 week of tramadol, codeine or dextropropoxyphene within 1 month before screening visit.
  4. Subjects who require NSAID treatment (except aspirin for cardiovascular indications) or cox-2-inhibitors during the study period.
  5. Subjects with history of, or ongoing, chronic condition(s), in addition to osteoarthritis, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis).
  6. Subjects scheduled for surgery that would fall within the study period.
  7. Subjects who currently abused substance or alcohol, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviours.
  8. Subjects with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma).
  9. Untreated depression or other psychiatric disorder in such way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
  10. Subjects who are currently taking hypnotics, anxiolytics or other central nervous system depressants that, in the Investigator's opinion, may pose a risk of additional CNS depression with study medication.
  11. Subjects who are currently taking adjuvant analgesics such as antidepressants and anti-convulsants.
  12. Dermatological disorder or non-intact skin at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
  13. Subjects who had received an intra-articular steroid injection within 6 weeks prior Screening Visit or subjects who require steroid treatment (oral, intra-muscular, intra-venous, intra-articular, epidural or other corticosteroid injections) during the study period.
  14. Subjects with joint evacuation 6 weeks prior Screening Visit and during the study.
  15. Subjects who are currently taking monoamine oxidase inhibitors (MAOI's) or have taken MAOI's within 2 weeks before Screening Visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276431

Locations
Sweden
Professor Jon Karlsson
Molndal, Sweden
Dr Bengt Olav Tengmark
Stockholm, Sweden
Sponsors and Collaborators
Mundipharma AB
  More Information

No publications provided

Responsible Party: Mundipharma AB
ClinicalTrials.gov Identifier: NCT01276431     History of Changes
Other Study ID Numbers: BUP4504, 2010-020748-37
Study First Received: January 10, 2011
Last Updated: May 1, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Buprenorphine
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

ClinicalTrials.gov processed this record on June 17, 2013