A prospective, multi-centre, open-label study to establish the equipotent dose ratio after switching from strong opioids to Transtec® in subjects with pain due to cancer - Transtec® in Cancer pai

• Conditions: cancer pain

• Registration Number: EUCTR2004-004624-13-GB
• Lead Sponsor: Barts and The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-22
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Subjects 18 years or older.
2.Subjects who have given their written informed consent.
3.At screening, 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 moderate to very severe cancer pain, whose pain has been satisfactorily controlled over the preceding two weeks with a stable dose of strong opioid of at least 30mg morphine (or equivalent) per day. Satisfactory control” is defined as recalled average daily pain scores as = 4 on an 11-point Numerical Rating Scale (0=no pain, 10=worst pain imaginable) and strong opioid stability as taking a stable daily dose of sustained-release strong opioid (oral or patch) and not requiring an average of more than two doses of immediate release morphine (or equivalent) [or >30% of their stable 24 dose, whichever is greater of that dose] for breakthrough per day.
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

Principal exclusion criteria (list the most important)
1.Subjects who have previously failed on Transtec® or Temgesic® therapy.
2.Contraindications to Transtec® or Temgesic® as listed in their respective Summary of Product Characteristics.
3.Subjects with documented or suspected alcohol or drug abuse, or who are strongly suspected of having an addictive personality.
4.Subjects for whom a treatment is planned within the four week study period that could significantly alter the degree or nature of pain, e.g. radiotherapy, chemotherapy, hormonal therapy, biphosphonate therapy, surgery, nerve block.
5.Subjects known to have a condition that in the investigator’s judgement precludes participation in the study.
6.Subjects with a significant psychiatric disorder in the opinion of the investigator or subjects receiving strong anti-psychotic medication.
7.Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
8.Subjects unable to comply with the study assessments and to complete the questionnaires.
9.Subjects who have previously been admitted to this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to establish clinically meaningful equipotency ratios between buprenorphine administered primarily transdermally and the strong opioids, morphine, oxycodone and fentanyl.<br><br>;Secondary Objective: The secondary objectives will be to confirm the absence of an analgesic ceiling effect with buprenorphine, across a broad range of pain severities, reflected by a wide range of daily doses of strong opioids; to confirm that the switch to buprenorphine is clinically effective and well-tolerated and to address quantitative and qualitative clinical differences in unwanted effects in order to provide a preliminary indication of the feasibility and any significant pharmaco-economic impact of switching from one strong opioid to another.;Primary end point(s): The primary efficacy response variable is the subjects’ reported pain intensity recorded in a diary card each day using an 11-point Numerical Rating Scale (0=no pain, 10=worst pain imaginable).