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

Phase 1

• Conditions: Moderate to Severe Cancer Pain; MedDRA version: 9.1Level: LLTClassification code 10058019Term: Cancer pain

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-27
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

At Visit 1:
1. Males and females, 18 years or older.
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 moderate to very severe cancer pain, whose pain has been satisfactorily controlled over the preceding two weeks with a stable dose of strong opioid (see footnote 1) 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) with no more than two doses of immediate release morphine [or equivalent] (or >30% of their 24 hour dose, whichever is greater) for breakthrough on average per day.
At Visit 2:
1. To be eligible to receive Transtec®, subjects must have continued to obtain satisfactory pain control from the stable dose of strong opioid, with no more than two doses of immediate release morphine [or similar] (or >30% of their stable 24 hour dose, whichever is greater) for breakthrough on average for at least three consecutive days prior to starting on Transtec®.

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

1. Subjects who have previously failed on Transtec®, morphine or Temgesic® therapy.
2. Contraindications to Transtec®, morphine 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, etc.
5. Subjects known to have a condition (e.g. hepatic or renal) 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