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 pain

Barts and The London NHS Trust0 个研究点目标入组 180 人开始时间: 2005年3月22日最近更新: 2012年5月1日

适应症

试验速览

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•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

•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.

发起方

Barts and The London NHS Trust