A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00399178
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : August 17, 2007
Information provided by:
Mundipharma AB

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Drug: Transdermal delivery system Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

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 identifier (NCT number): NCT00399178

Dr Mats Karlsson
Falkoping, Parkgatan 6C, Sweden, 521 43
Sponsors and Collaborators
Mundipharma AB
Principal Investigator: M Karlsson, Med Identifier: NCT00399178     History of Changes
Other Study ID Numbers: 2006-003233-32
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: August 17, 2007
Last Verified: November 2006

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

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