EUCTR2007-002087-10-DE进行中（未招募）不适用
A randomised, double -blind, placebo-controlled, parallel group study to assess the efficacy and safety of 4 weeks treatment with sodium picosulphate [Dulcolax®, Laxoberal®] drops 10 mg administered orally, once daily, in patients with functional constipation.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •3.3.1 Inclusion criteria
- •1. Male and female patients, aged 18 and above
- •2. Suffering from functional constipation, according to their medical history, as defined
- •by the Rome III diagnostic criteria (Appendix 10.3), i.e.:
- •Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to
- •a. Must include 2 or more of the following:
- •o straining during at least 25% of the defecations
- •o lumpy or hard stools in at least 25% of the defecations
- •o sensation of incomplete evacuation for at least 25% of the defecations
- •o sensation of anorectal obstruction/blockade for at least 25% of the
- •defecations
- •o manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital
- •evacuation, support of the pelvic floor)
- •o fewer than 3 defecations per week
- •b. Loose stools are rarely present without the use of laxatives
- •c. There are insufficient criteria for irritable bowel syndrome (IBS) (i.e. recurrent
- •abdominal pain or discomfort is not the predominant symptom associated with
- •defecation or a change in bowel habit, and with features of disordered defecation)
- •3. Able and willing to complete a daily e-diary
- •4. Able and willing to use the trial rescue medication (i.e. 10 mg bisacodyl [Dulcolax®]
- •suppositories)
- •5. Signed and dated written informed consent prior to enrolment into the study in
- •accordance with GCP and local legislation
- •At Visit 2 (i.e. at the end of the baseline period), patients must comply with the following
- •additional inclusion criteria to be eligible for entry into the treatment phase:
- •6. Functional constipation is confirmed by e-diary data at the end of the baseline period,
- •according to the following definition:
- •a. An average of less than 3 CSBMs per week, together with at least one of the
- •following symptoms occurring at least 25% of the time:
- •o straining
- •o incomplete evacuation
- •o lumpy or hard stools (i.e. type 1 or type 2 stools according to the 7-point
- •Bristol Stool Form Scale, see Appendix 10.4)
- •7. Compliant with the use of the e-diary throughout the baseline period (compliance is
- •defined as completing 80% of the e-diary evening reports, see Section 5.1.1.1)
- •8. Compliant with the use of the trial rescue medication (i.e. 10 mg bisacodyl
- •[Dulcolax®] suppositories) throughout the baseline period. Compliance is defined as
- •o rescue medication may be used if there has not been a bowel movement for more
- •than 72 hours
- •o rescue medication may not be used on either day -1 or on the day of 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •3.3.2 Exclusion criteria
- •At the screening visit (Visit 1), patients must not comply with any of the following exclusion
- •criteria to be eligible for entry into the baseline period:
- •1. Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of
- •2. Patients whose constipation is caused by primary organic disease of the colon or
- •pelvic floor
- •3. Patients with metabolic disorders, neurological disorders, severe or psychiatric
- •disorders, or any other significant disease or intercurrent illness (e.g.
- •abdominal/gastrointestinal surgery) that, in the Investigators’ opinion, would interferewith participation in the trial
- •4. Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the
- •Investigators’ opinion, would interfere with participation in the trial
- •5. Patients with a known hypersensitivity to sodium picosulphate, bisacodyl or any other
- •ingredient in the study medication (sodium picosulphate [Dulcolax®, Laxoberal®] and
- •matching placebo drops, bisacodyl [Dulcolax®] suppositories)
- •6. Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such
- •as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration
- •7. Patients with anal fissures or ulcerative proctitis with mucosal damage
- •8. Patients with known clinically significant abnormal electrolyte values
- •9. Patients whose concomitant therapy includes an opioid medication (e.g. morphine,
- •10. Constipation which, in the Investigators’ opinion, is caused by medication (e.g.
- •anticholinergics)
- •11. Patients who are not willing to discont inue the use of prohibited concomitant therapy
- •(see Section 4.2.2)
- •12. Pre-menopausal women (last menstruation £ 1 year prior to signing informed consent)
- •i. are nursing (breast-feeding) or who are pregnant OR
- •ii. who are of child-bearing potential and are not practicing an acceptable method of
- •birth control, or do not plan to continue using this method throughout the study.
- •Acceptable methods of birth control include:
- •1. transdermal patch
- •2. intra-uterine devices/systems (IUDs/IUSs)
- •3. oral, implantable or injectable contraceptives
- •4. sexual abstinence
- •5. sterilisation or a vasectomised partner
- •13. Participation in another trial with an investigational product with 1 month of
- •enrolment into this study
- •14. Drug or alcohol abuse
- •15. Concomitant use of antibiotics
- •At Visit 2 (i.e. at the end of the baseline period), patients must not comply with any of the
- •following additional exclusion criteria if they are to remain eligible for entry into the
- •treatment phase:
- •16. Clinically significant abnormal electrolyte values identified following the central
- •laboratory analysis at the screening visit (Visit 1)
- •17. Loose or watery stools (i.e. type 6 or type 7 according to the 7-point Bristol Stool
- •Form Scale, see Appendix 10.4) for a total of 3 days or more during the baseline
- •18. Persons committed to an institution following an order issued by either the judicial or administrative authorities (cf. section 40, para 1, clause 3 No. 4 German Medicines Act.)
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