E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with severe chronic pain due to osteoarthritis of the knee or hip, awaiting surgical joint replacement surgery. ICD10: M16.50 & M17.30 |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to investigate whether chronic buprenorphine therapy affects the usage of opioids intraoperatively and postoperatively. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the opioid usage intraoperatively. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
The final pre-op patch is taken off at two different time-points (pts randomised into two groups) |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial will be Last Patient, Last Visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |