Norspan Efficacy and Safety Among Elderly Subjects

Phase 4

Completed

• Conditions: Osteoarthritis Pain of the Hip and or Knee
• Interventions: Drug: Buprenorphine transdermal patch

• Registration Number: NCT01276431
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Study Start: 2011-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine transdermal patch	Buprenorphine transdermal patch	For two age groups: 50-60 years and \>= 75 years of age

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Western Ontario & McMaster Universities OA Index
European QOL Health Questionnaire
Sleep disturbance & quality of sleep questions
Patients global assessment of pain relief
Investigators global assessment of pain relief
Incidence of rescue medication

Trial Locations

Locations (2)

Dr Bengt Olav Tengmark; 🇸🇪 Stockholm, Sweden

Professor Jon Karlsson; 🇸🇪 Molndal, Sweden