A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
This study has been completed.
Information provided by:
First received: November 10, 2006
Last updated: August 16, 2007
Last verified: November 2006
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.
Drug: Transdermal delivery system
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
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:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
- OA diagnosis
- BS11 greater than or equal to 4 at base line
- Not adequately pain relieved with 4,000 mg paracetamol daily
- 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
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
|Dr Mats Karlsson
|Falkoping, Parkgatan 6C, Sweden, 521 43 |
||M Karlsson, Med
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 10, 2006
||August 16, 2007
||Sweden: Medical Products Agency
Keywords provided by Mundipharma AB:
Norspan versus Tramadol
Efficacy and safety
OA pain of the hip and/or knee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents