A multi-center, randomized, double-blind, placebo-controlled, crossover study in women with irritable bowel syndrome to evaluate feasibility and reproducibility of barostat assessments of colorectal sensation during colorectal distention and its pharmacological modulation using octreotide

• Conditions: Irritable Bowel Syndrom; MedDRA version: 9.1Level: PTClassification code 10023003Term: Irritable bowel syndrome

• Registration Number: EUCTR2007-004994-25-SE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

1. Females aged 18-65 years.
2. A positive diagnosis of IBS according to the Rome III criteria: At least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort associated with 2 or more of the following:
•Improvement with defecation; and/or
•Onset associated with a change in frequency of stool; and/or
•Onset associated with a change in form (appearance) of stool
- discomfort means an uncomfortable sensation not described as pain.
3. Subjects must either:
•have been surgically sterilized (bilateral oophorectomy) or hysterectomized at least 6 months prior to screening. Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions form of the eCRF.
•be postmenopausal, i.e. must have no regular menstrual bleeding for at least 1 year prior to inclusion. Menopause will be confirmed by a plasma 17?-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L.
•female subjects of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or diaphragm plus condom, from 1 week before dosing until the end of study. In addition, appropriate precautions will be taken (e.g. Informed Consent, detailed counseling, abstinence during study, and negative pregnancy tests at screening and each baseline, with repetition of pregnancy test at the end of study).
4. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant or breast-feeding women.
2. Body mass index (BMI) of <18 or >35.
3. Smoking of greater than 10 cigarettes per day and/or urine cotinine > 200ng/mmol at screening.
4. History of or evidence for structural diseases/conditions that affect the gastrointestinal system including prior intestinal or colonic surgery (except appendectomy).
5. Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity; specifically patients with suspected idiopathic chronic constipation must not be included.
6. Evidence of occult blood at stool analysis, or history of rectal bleeding.
7. Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception such as laxatives, prokinetics, erythromycin, 5-HT3 antagonists, 5-HT4 agonists, narcotics, pain medication, antispasmodic agents, or serotonin re-uptake inhibitors or tricyclic antidepressants.
8. Use of intra-vaginal devices (e.g. tampons) during colorectal barostat procedures.
9. Using or planning to use drugs or agents during the study period that alter blood coagulation like warfarin, heparin, NSAIDs or aspirin.
10. Diabetes mellitus or poorly controlled thyroid disease (hypo- or hyperthyroidism).
11. Known gallstones; history of biliary colic pain; history of pancreatitis.
12. Any clinical evidence (including physical exam, ECG, laboratory tests) of significant intercurrent medical conditions such as cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic or of any disease that may interfere with the objectives of the study.
13. Clinically significant bradycardia with potential to interfere with procedure induced vagal tone (Investigators may be guided by a cut-off heart rate of < 50 bpm).
14. Psychosis, schizophrenia, mania or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential subject.
15. Symptoms of a significant clinical illness in the preceding two weeks.
16. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
17. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
18. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.

Study & Design

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