A Treatment Investigational New Drug (tIND) Program of Tegaserod in Women With Irritable Bowel Syndrome With Constipation or With Chronic Idiopathic Constipation
Expanded access is no longer available for this treatment.
Information provided by:
First received: August 3, 2007
Last updated: November 16, 2010
Last verified: November 2010
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.
Irritable Bowel Syndrome With Constipation
Chronic Idiopathic Constipation
What is Expanded Access?
||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
Other Name: Zelnorm
|Ages Eligible for Study:
||18 Years to 54 Years
|Genders Eligible for Study:
- For patients with IBS-C: Women of 18-54 years of age with IBS-C according to the Rome III criteria.
- For patients with Chronic Idiopathic Constipation: Women of 18-54 years of age with CIC according to the Rome III criteria .
- 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.
- Patients signed the informed consent
- 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)
- 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
- 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
- Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
- History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
- Uncompensated depression or anxiety or suicidal ideation or behavior.
- 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
- 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
- Pregnant women or breastfeeding women; fertile women who are not currently practicing medically approved method of contraception
- Participating in other investigational studies concurrently or within 1 month prior to entering this tIND program
- Hypersensitive to tegaserod or to any of the excipients
- Patients who had tolerability or safety concerns with prior use of tegaserod.
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||External Affairs, Novartis
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 3, 2007
||November 16, 2010
||United States: Food and Drug Administration
Keywords provided by Novartis:
Tegaserod, treatment IND, irritable bowel syndrome with constipation, IBS-C, chronic idiopathic constipation, CIC, chronic constipation, CC
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Digestive System Diseases
Serotonin Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs