Patients with severe chronic pain due to osteoarthritis of the knee or hip, awaiting surgical joint replacement surgery. ICD10: M16.50 & M17.30
Conditions
Interventions
Trade Name: TRANSTEC® 35 µg/h transdermal patch
Product Name: TRANSTEC® 35 µg/h transdermal patch
Product Code: TRANSTEC® 35 µg/h transdermal patch
Phar
Sponsors
Barts and The London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have completed the first two weeks of PRG-BUP-03/01 and require at least one Transtec® patch to achieve pain relief. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria: 1. Subjects who have previously failed on Transtec® therapy. 2. Subjects who have received treatment with a potent opioid in the four weeks preceding study entry. 3. Subjects who are breastfeeding. 4. Contraindications to Transtec® or Temgesic® as listed in their respective Summary of Product Characteristics. 5. Subjects with documented or suspected alcohol or drug abuse, or who are suspected of having an addictive personality. 6. Subjects to whom any of the following applies • Major trauma to the target joints in the six months preceding study entry • Infection in the target joints in the six months preceding study entry; • Apparent avascular necrosis in the target joints in the six months preceding study entry; • Intra-articular injections of corticosteroids in the target joints in the two months preceding study entry, or hyaluronan injections in the target joints in the six months preceding study entry. • Subjects who have started any form of physiotherapy, massage or physical therapy, transcutaneous electrical nerve stimulation (TENS) in the three weeks preceding the study. Such therapies can continue if they were started more than three weeks before the start of the study and if they continue at the same frequency of administration throughout the study. 7. Subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain. 8. Subjects known to have a condition that in the investigator’s judgement precludes participation in the study. 9. Subjects with a significant psychiatric disorder (including depression) or subjects receiving anti-psychotic medication. 10. Subjects who have received an investigational drug or have used an investigational device in the 30 days preceding to study entry except those used in PRG-BUP-03/01. 11. Subjects unable to comply with the study assessments and to complete the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether chronic buprenorphine therapy affects the usage of opioids intraoperatively and postoperatively.;Secondary Objective: The secondary objective is to investigate whether chronic buprenorphine therapy has any impact upon pain intensity, pain relief and adverse events, in the first 12 hours postoperatively.;Primary end point(s): The primary efficacy variable is the opioid usage intraoperatively. | — |
Countries
United Kingdom
Outcome results
None listed