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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00511771
First received: August 3, 2007
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome With Constipation
Chronic Idiopathic Constipation
Drug: Tegaserod

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Intervention Details:
    Drug: Tegaserod
    Tegaserod maleate
    Other Name: Zelnorm
  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Female
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00511771     History of Changes
Other Study ID Numbers: CHTF919A2433
Study First Received: August 3, 2007
Last Updated: November 16, 2010
Health Authority: 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:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014