A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399178
• Other study ID #: 2006-003233-32
• Secondary ID: BUP4009
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2006
• Last updated: August 16, 2007
• Start date: November 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2006
• Source: Mundipharma AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Transdermal delivery system

Locations

Country	Name	City	State
Sweden	Dr Mats Karlsson	Falkoping	Parkgatan 6C

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.