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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002612-28-GB

Enrollment

850

Registered

2005-02-24

Start date

2004-11-17

Completion date

Unknown

Last updated

2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dyspepsia

Interventions

Trade Name: Zelmac Product Name: HTF919 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. QoL using a disease specific questionnaire (Nepean Dyspepsia Index), Work productivity activity Impairmenet questionnnaire (WPAI), and Patient Peception of study medication-Dyspepsia questionnaire. Efficacy on satisfactory relief of symptoms of dyspepsia ;Primary end point(s): safety assessements	—

Measure

Time frame

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. QoL using a disease specific questionnaire (Nepean Dyspepsia Index), Work productivity activity Impairmenet questionnnaire (WPAI), and Patient Peception of study medication-Dyspepsia questionnaire. Efficacy on satisfactory relief of symptoms of dyspepsia ;Primary end point(s): safety assessements

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026