Joint pain personalised treatment assessment to investigate the acceptability of modified release oxycontin for managing chronic pain in patients with osteoarthritis of the hip - Joint Pain PTA

Phase 1

• Conditions: Hip Osteoarthritis

• Registration Number: EUCTR2005-004527-19-GB
• Lead Sponsor: MRC Health Services Research Collaboration

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

(1) Aged older than 65 years with symptomatic OA of the hip
(2) Chronic pain, defined as pain being present for at least three months, scoring 4 or more on an eleven point pain scale
(3) Able to walk six meters,
(4) Living in Bristol and been referred to the Avon Orthopaedic Centre in North Bristol Health Care Trust for total hip arthroplasty,
(5) Patients whose primary care clinicians have agreed to support the study
(6) Patients who are currently being prescribed NSAID for their pain
(7) Patients who give written informed consent to take part in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1) Those patients with severe co-morbidity whom it is believed would be unable to complete the trial,
(2) Previous intolerance/severe adverse events to Paracetamol or OxyContin,
(3) Current or previous history of alcohol abuse (assessed using the CAGE questionnaire)
(4) Current or previous history of problem drug use
(5) Current or previous history of a psychotic illness
(6) Patient who primary care clinicians considers may be at risk of additional central nervous system depressant effects with the study medication
(7) Lack of ability to take oral medication
(8) Patients with dementia
(9) Patients without primary care clinician approval
(10) Patients unable to give informed consent
(11) Patients without a reduction in pain by at least 2 points on an eleven-point pain scale within the two-week titration period.
(12) Patients who the researchers consider to be unsuitable to take part in the study for any other reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified