EUCTR2006-002632-21-GB进行中（未招募）1 期
A double-blind, randomised, placebo controlled, single dose, two-period crossover study to investigate the therapeutic potential of the TRPV1 antagonist SB-705498 in treatment of subjects with rectal hypersensitivity including irritable bowel syndrome.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for Group 1 (Faecal Urgency) Patients.
- •A subject will be eligible for inclusion in this study only if all of the following criteria
- •Female or male subjects aged 18 to 65. Women may be of child bearing potential or
- •of non-child bearing potential. Women of child bearing potential must use an
- •effective method of contraception (see below).
- •Females of non-child bearing potential are defined as:
- •Post-menopausal females, being amenorrhoeic for at least 2 years with an
- •appropriate clinical profile, e.g., age appropriate, history of vasomotor
- •symptoms. However, if indicated this should be confirmed by oestradiol and
- •FSH levels consistent with menopause (according to local laboratory ranges).
- •Pre-menopausal females with a documented hysterectomy (medical report
- •verification) and/or bilateral oophorectomy. In the case of oophorectomy alone,
- •only when the reproductive status of the woman has been confirmed by follow
- •up hormone level assessment.
- •Faecal urgency, increased stool frequency, faecal incontinence and rectal
- •hyperalgesia as defined by Chan et al., 2003, with no previous diagnosis of IBS.
- •Pre-study screening and baseline ECG, which, in the opinion of the Principal
- •Investigator has no abnormalities that will compromise safety in this study.
- •Clinical laboratory tests at screening showing no clinically significant abnormalities
- •in the opinion of the Principal Investigator.
- •Signed and dated written informed consent prior to admission to the study.
- •Able to understand and comply with protocol requirements, instructions and
- •protocol-stated restrictions.
- •If on anti-diarrhoeal medications for faecal urgency / frequency, these have to be at a stable dose for 2 weeks prior to randomisation. In addition, anti-diarrhoeal
- •medications which are opioids have to be non-systemically absorbed (e.g. loperamide is permitted if on a stable dose for 2 weeks prior to randomisation but not codeine phosphate).
- •Inclusion Criteria for Group 2 (Irritable Bowel Syndrome) Patients
- •A subject will be eligible for inclusion in this study only if all of the following criteria
- •Female or male subjects aged 18 to 65. Women may be of child bearing potential or
- •of non-child bearing potential (as defined for Group 1). Women of child bearing
- •potential must use an effective method of contraception (see 5.2.3 Exclusion Criteria
- •for Groups 1 and 2).
- •Has irritable bowel syndrome (IBS) as defined by Rome II criteria [Appendix 3,
- •Drossman, 2000],
- •Has rectal hyperalgesia as defined by Chan et al., 2003 and determined using the
- •protocol outline in barostat study published by Cremonini et al in 2005.
- •Pre-study screening and baseline ECG, which, in the opinion of the Principal
- •Investigator has no abnormalities that will compromise safety in this study.
- •Clinical laboratory tests at screening showing no clinically significant abnormalities
- •in the opinion of the Principal Investigator.
- •Signed and dated written informed consent prior to admission to the study.
- •Able to understand and comply with protocol requirements, instructions and
- •protocol-stated restrictions.
- •If on anti-diarrhoeal medications or laxatives for control of bowel habit, these have
- •to be at a stable dose for 2 weeks prior to randomisation
- •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)
- •F.1.3.1 Number of subjects for this age
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria
- •Other GI or pain conditions that in the opinion of Investigator may interfere with
- •study procedures or confound data interpretation.
- •Any clinical or biological abnormality found at screen (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically
- •significant [e.g., major depression (within the past 3 months)].
- •Any concurrent illness or disability that may affect the interpretation of clinical
- •efficacy and/or safety data or otherwise contraindicates participation in this clinical
- •study (i.e., current malignancy, HIV, significant mental illness).
- •History of alcohol, substance or drug abuse within the last year.
- •Uncontrolled hypertension at the Screening Visit, defined as persistent (after 3
- •readings) systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg;
- •measured after 5 min supine rest.
- •A history or presence of multiple cardiovascular risk factors such as, but not limited
- •to family history, myocardial infarction, coronary artery disease, vasospastic angina,
- •heart failure, cardiac arrhythmias or history or presence of cerebrovascular disease,
- •including transient ischemic attack, stroke or peripheral arterial disease.
- •QTcB > 430 msec for men or > 450 msec for women on screening 12-lead ECG.
- •Participation in a trial with a new chemical entity within 3 months before the start of
- •the study or participation in any other research trial within 30 days prior to the first
- •dose of current study medication.
- •A history of drug or other allergy or any other reason that, in the opinion of the
- •physician responsible, contraindicates their participation.
- •Unable to withdraw from analgesic medications for their rectal hyperalgesia (opioiddependent patients can be included if they are willing to withdraw from their opiate medication with a nineteen day washout period).
- •Unable / unwilling to refrain from taking the prohibited medications during the study
- •An unwillingness of male subjects to abstain from sexual intercourse with pregnant
- •or lactating women from the time of the first dose of study medication until five halflives (nineteen days) following administration of the last dose of study medication.
- •An unwillingness of the male subject to use a condom/spermicide in addition to
- •having their female partner use another form of contraception such as IUD,
- •diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal
- •implants or a tubal ligation if the woman could become pregnant from the time of the
- •first dose of study medication until 84 days following administration of the last dose
- •of study medication.
- •Female subjects who are pregnant, breast feeding, or have a positive serum
- •pregnancy test or a positive urine pregnancy test either at screening or pre-dose on
- •each dosing session.
- •An unwillingness of the female subject to use an appropriate form of contraception.
- •Appropriate forms of contraception are defined as:
- •a. Abstinence – The lifestyle of the female should be such that there is complete
- •abstinence from intercourse from at least the commencement of their last normal
- •period prior to the first dose of study medication and to continue until the first
- •normal period (defined as normal for the woman, both in terms of duration and
- •quantity of menses) after treatment or 15 days after the last dose of medication,
- •whichever is the longest.
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