A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

This study has been completed.

First Received on November 10, 2006. Last Updated on August 16, 2007 History of Changes

Sponsor:	Mundipharma AB
Information provided by:	Mundipharma AB
ClinicalTrials.gov Identifier:	NCT00399178

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 IV

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:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Tramadol

U.S. FDA Resources

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

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
Tramadol
Narcotics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012