NCT00399178

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 17, 2007

Status Verified

November 1, 2006

First QC Date

November 10, 2006

Last Update Submit

August 16, 2007

Conditions

Osteoarthritis

Keywords

OsteoarthritisNorspan versus TramadolRandomisedEfficacy and safetyOA pain of the hip and/or knee

Outcome Measures

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.

Interventions

Transdermal delivery systemDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OA diagnosis
  • BS11 greater than or equal to 4 at base line
  • Not adequately pain relieved with 4,000 mg paracetamol daily

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Mats Karlsson

Falköping, Parkgatan 6C, 521 43, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • M Karlsson, Med

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Start

November 1, 2006

Study Completion

June 1, 2007

Last Updated

August 17, 2007

Record last verified: 2006-11

Locations

SE(1)