Irritable bowel syndrome MedDRA version: 16.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Constella
Pharmaceutical Form: Capsule
INN or Proposed INN: linaclotide
CAS Number: 851199-59-2
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 290-
Sponsors
almirall
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate possible predictors of response to linaclotide, specifically the prevalence of pain on the altered bowel (proportion pain / constipation), which can allow the identification of profiles of IBS patients who would benefit from treatment;Secondary Objective: asses whether the response at 4 weeks predicts response at 12 weeks Evaluate the impact of linaclotide on non-intestinal symptoms, digestive and non-digestive, associated with IBS.;Primary end point(s): Clinical response at 12 weeks defined as a subjective improvement on a Likert scale of "Cataloging opinion of the answer" as better or much better compared to baseline and accompanied by a decrease IBSSS score above 30% of baseline or achieve a score below 75 points;Timepoint(s) of evaluation of this end point: baseline, week 4 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Anxiety-depresion Score, PHQ12 Score Non intestinal digestive symptoms Score fear / worry Score Confidence in the drug baseline severity (IBSSS);Timepoint(s) of evaluation of this end point: baseline, week 4 and weeek 12 | — |
Countries
Spain
Contacts
Public ContactUCICEC
Fib Hospital Clínico San Carlos
Outcome results
None listed