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OpenTrials
Completed

NCT Number: NCT00399178

A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr Mats Karlsson

Falköping, Parkgatan 6C, 521 43, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal delivery system

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mundipharma AB

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Study completion
2007
First posted
Nov 14, 2006
Registry last updated
Aug 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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