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Norspan Efficacy and Safety Among Elderly Subjects

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ClinicalTrials.gov Identifier: NCT01276431
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : February 6, 2014
Information provided by (Responsible Party):
Mundipharma AB

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Pain of the Hip and or Knee Drug: Buprenorphine transdermal patch Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Buprenorphine transdermal patch
For two age groups: 50-60 years and >= 75 years of age
Drug: Buprenorphine transdermal patch

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Western Ontario & McMaster Universities OA Index
  2. European QOL Health Questionnaire
  3. Sleep disturbance & quality of sleep questions
  4. Patients global assessment of pain relief
  5. Investigators global assessment of pain relief
  6. Incidence of rescue medication

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276431

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

Additional Information:
Responsible Party: Mundipharma AB
ClinicalTrials.gov Identifier: NCT01276431     History of Changes
Other Study ID Numbers: BUP4504
2010-020748-37 ( EudraCT Number )
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists