A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Transdermal delivery system

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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M Karlsson, Med

Role: PRINCIPAL_INVESTIGATOR

Locations

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Dr Mats Karlsson

Falköping, Parkgatan 6C, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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BUP4009

Identifier Type: -

Identifier Source: secondary_id

2006-003233-32