A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

This study has been completed.
Sponsor:
Information provided by:
Mundipharma AB
ClinicalTrials.gov Identifier:
NCT00399178
First received: November 10, 2006
Last updated: August 16, 2007
Last verified: November 2006
  Purpose

To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.


Condition Intervention Phase
Osteoarthritis
Drug: Transdermal delivery system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.

Resource links provided by NLM:


Further study details as provided by Mundipharma AB:

Primary Outcome Measures:
  • Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.

Secondary Outcome Measures:
  • Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.

Estimated Enrollment: 160
Study Start Date: November 2006
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • OA diagnosis
  • BS11 greater than or equal to 4 at base line
  • Not adequately pain relieved with 4,000 mg paracetamol daily

Exclusion Criteria:

  • Treated with high potent opioids for their OA pain
  • Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
  • Other chronic conditions requiring frequent analgesic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399178

Locations
Sweden
Dr Mats Karlsson
Falkoping, Parkgatan 6C, Sweden, 521 43
Sponsors and Collaborators
Mundipharma AB
Investigators
Principal Investigator: M Karlsson, Med
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399178     History of Changes
Other Study ID Numbers: 2006-003233-32, BUP4009
Study First Received: November 10, 2006
Last Updated: August 16, 2007
Health Authority: Sweden: Medical Products Agency

Keywords provided by Mundipharma AB:
Osteoarthritis
Norspan versus Tramadol
Randomised
Efficacy and safety
OA pain of the hip and/or knee

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

ClinicalTrials.gov processed this record on September 18, 2014