Patients with severe chronic pain (6 or more on a 11-point NRS) in the hips or knees due to osteoarthritis, failing on their current analgesic therapy. ICD 10: M16.50 & M17.30
Conditions
Interventions
Trade Name: Transtec 35 µg/h transdermal patch
Product Name: Transtec 35 µg/h transdermal patch
Pharmaceutical Form: Transdermal patch
Trade Name: Temg
Sponsors
Barts and The London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects older than 40 years of age. 2. Subjects who have given their written informed consent. 3. At baseline, female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test. 4. Subjects with severe OA pain of the hip or knee, whose pain has not been adequately controlled with weak opioids, with or without paracetamol. Severe pain is defined as a clinic pain score of 6 or more on an 11-point Numerical Rating Scale (0=no pain, 10=worst pain imaginable) at screening. 5. Subjects who have required analgesic therapy, for at least 60 out of the last 90 days. At randomisation: Patients must have required an average of at least one 0.2mg Temgesic tablet per day over the last patch administration period in order to be randomised. 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, Temgesic or Sevredol as listed in their respective Summary of Product Characteristics texts. 5. Subjects with documented or suspected alcohol or drug abuse, or who are suspected of having an addictive personality. 6. Subjects with a significant psychiatric disorder (including depression) or subects receiving anti-psychotic medication. 7. Subjects who are experiencing another type of continuous pain that stands out in comparison with OA pain (e.g. fibromyalgia) and may compromise their target joint pain assessments. 8. Subjects to who any of the following applies: - major trauma to the target joint in the six months preceding study entry - infection in the target joint in the six months preceding study entry - apparent avascular necrosis in the target joint in the six months preceding study entry - intra-articular injections of corticosteroids in the target joint in the two months preceding study entry, or hyalorunan injections in the target joint 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 study entry. Such therapies can continue if they were started more thsn three weeks before the start of the study and if they continue at the same frequency of administration throughout the study. 9. Subjects for whom a treatment is planned within the study period that could alter the degree or nature of pain. 10. Current history of functional disorder of the following systems: gastrointestinal, renal, hepatic, respiratory, cardiovascular, central nervous system. likely to adversely affect the patient's participation in the study. 11. Subjects wo have received an investiagtional drug or have used an investigational device in the 30 days preceding study entry. 12. Subjects unable to comply with the study assessments or complete the questionnaires. 13. Subjects who have previously been admitted to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate whether the addition of morphine to chronic buprenorphine therapy produces a different clinical outcome to that observed when adding buprenorphine to existing buprenorphine therapy. So as to have the broadest clinical relevance, outcome will be assessed at the end of each double-blind period, and comprise questioning on the global satisfaction with analgesic treatment. ;Secondary Objective: The secondary objectives will be to investigate whether the addition of buprenorphine or morphine to chronic buprenorphine therapy has any impact upon pain intensity, pain relief, exercise testing, functionality, quality of life and adverse events, and at which dose levels these are observed.; Primary end point(s): The primary efficacy variable is the number of responders. A responder is defined as a patient who indicates satisfaction with analgesic treatment, i.e. provides an answer of at least 'fair' when asked the question: "Taking into account your pain relief and any side effects you may have had, how effective did you find the pain treatment?" before and at the end of each blinded treatment period, using a labeled categorical scale of: none, poor, fair, good, or very good. Treatment satisfaction (response) is defined as a 'fair' or better overall treatment evaluation, and conversely, treatment dissatisfaction (non-response) is defined as a poor treatment evaluation. | — |
Countries
United Kingdom
Outcome results
None listed