Evaluation of predictors of response to linaclotide in patients with irritable bowel syndrome and explore the impact on intestinal symptoms

• Conditions: Irritable bowel syndrome; MedDRA version: 16.1Level: PTClassification code 10023003Term: Irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-001248-67-ES
• Lead Sponsor: almirall

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age betwen 18 and 70 years old
2. Sex: male and female
3. Meet the Rome III criteria for the diagnosis of constipation predominant IBS
4. Moderate-severe constipation IBS, defined as a score greater than 175 points IBSSS
5. Clinical explorations to support the diagnosis of IBS:
a. All patients: blood in less than six months that shows no anemia
b. Over 50 years: colonoscopy to the cecum without abnormalities explaining the symptoms in the last five years.
6. Sign informed consent: Patients should give informed consent in writing and must be able to read and understand it.
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1. Women of childbearing age who are unwilling or unable to use valids methods of contraception during the study period and up to 4 weeks after finishing.
2. Women of childbearing age who use an invalid method of contraception.
3. Pregnant or breast-feeding.
4l. Women with a positive pregnancy test at the time of enrollment or prior to study drug administration.

Study & Design

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