A Treatment Investigational New Drug (tIND) Program of Tegaserod in Women With Irritable Bowel Syndrome With Constipation or With Chronic Idiopathic Constipation

A Treatment Investigational New Drug (tIND) Program of Tegaserod 6 mg Bid Given Orally in Women Adult Patients With Irritable Bowel Syndrome With Constipation or With Chronic Idiopathic Constipation

To provide tegaserod to eligible women adult patients who did not have satisfactory improvement of their irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) symptoms with other available treatment(s) and / or patients who had satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC.

Study Overview

• Status: No longer available
• Conditions: Irritable Bowel Syndrome With Constipation; Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: Tegaserod

• Study Type: Expanded Access

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. For patients with IBS-C: Women of 18-54 years of age with IBS-C according to the Rome III criteria.
2. For patients with Chronic Idiopathic Constipation: Women of 18-54 years of age with CIC according to the Rome III criteria .
3. Patients who did not have satisfactory symptom improvement of their IBS-C or CIC symptoms with other available treatment(s) and / or patients who had satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC. Satisfactory symptom improvement will be assessed by the patient.
4. Patients signed the informed consent

Exclusion Criteria:

1. History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
2. Patients who have uninvestigated symptoms suggestive of a cardiovascular ischaemic disease such as chest pain or chest discomfort, shortness of breath, sudden onset of weakness of the arms or the legs, difficult talking or loss of sensation etc
3. Presence of any cardiovascular risk factors according to the NIH guideline [NIH Publication No. 01-3670] (such as hypertension, hyperlipidemia, diabetes mellitus, active smoking, obesity and family history of premature coronary heart disease) as assessed by the investigator
4. Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
5. History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
6. Uncompensated depression or anxiety or suicidal ideation or behavior.
7. Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia
8. Evidence of cathartic colon or a history of drug (including laxative) or alcohol abuse, that in the Investigator's opinion, the patient is likely to continue to abuse these substances during the tIND program period
9. Pregnant women or breastfeeding women; fertile women who are not currently practicing medically approved method of contraception
10. Participating in other investigational studies concurrently or within 1 month prior to entering this tIND program
11. Hypersensitive to tegaserod or to any of the excipients
12. Patients who had tolerability or safety concerns with prior use of tegaserod.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: December 6, 2022
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022

Study Registration Dates

• First Submitted: August 3, 2007
• First Submitted That Met QC Criteria: August 3, 2007
• First Posted (Estimate): August 6, 2007

Study Record Updates

• Last Update Posted (Estimate): November 18, 2010
• Last Update Submitted That Met QC Criteria: November 16, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Tegaserod, treatment IND, irritable bowel syndrome with constipation, IBS-C, chronic idiopathic constipation, CIC, chronic constipation, CC
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Tegaserod
• Other Study ID Numbers: CHTF919A2433

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No