Official Title: “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 Type: Expanded Access

Study Design: N/A

Intervention(s) in this Clinical Trial

• Drug: Tegaserod
  • Tegaserod maleate

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 54 Years

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00511771

Study ID Number: CHTF919A2433

ClinicalTrials.gov Identifier: NCT00511771

Health Authority: United States: Food and Drug Administration