A one year, open label, multi-center, extension study to CHTF919D2301 to assess the long term safety of tegaserod 6 mg bid given orally in female patients with symptoms of dyspepsia - D2301E1

Conditions: dyspepsia

Registration Number: EUCTR2004-002612-28-GB

Lead Sponsor: ovartis Pharmaceuticals UK Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 850

Inclusion Criteria

1. fullfilled eligibility criteria in CHTF919D2301 and successfully completed the double blind phase

2. demonstrated ability to communicate well with the investigator

3. willingness to comply with the requirements of the long term study
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Early discontinuation from the double blind phase of CHTF919D2301
2. History of serious consequences of diarrhea
3. History of ischemic colitis confirmed by colonoscopy during the double blind phase or prior to entry into the double blind phase
4. Severe abdominal pain or rectal bleeding not attributed only to hemorrhoids, anal fissure or other known cause

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long gterm safety of tegaserod (6mg bid) at 6 months in female patients with symptoms of dyspepsia;Secondary Objective: The long term safety of tegaserod 6 mg bid at 1 year in female patients with symptoms of dyspepsia.<br><br>QoL using a disease specific questionnaire (Nepean Dyspepsia Index),<br>Work productivity activity Impairmenet questionnnaire (WPAI), and Patient Peception of study medication-Dyspepsia questionnaire.<br><br>Efficacy on satisfactory relief of symptoms of dyspepsia ;Primary end point(s): safety assessements

Secondary Outcome Measures