Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Dyspepsia Clinical Trial

Official title:

Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232089
• Other study ID #: CHTF919D2302
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: November 16, 2016
• Start date: May 2004
• Est. completion date: June 2006

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1296
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients, 18 years and older

• Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months.

Exclusion Criteria:

• Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline.

• Current or history of erosive esophagitis confirmed by EGD

• Heartburn occurring 3 or more days a week.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Tegaserod

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vakil N, Laine L, Talley NJ, Zakko SF, Tack J, Chey WD, Kralstein J, Earnest DL, Ligozio G, Cohard-Radice M. Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials. Am J Gastroenterol. 2008 Aug;103(8):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating)
Secondary	Weekly assessment of satisfactory relief of dyspepsia.
Secondary	Daily assessment of percentage of patients responding on average severity score.
Secondary	For each week assessment of average daily severity score.
Secondary	Percentage of days with satisfactory relief of dyspepsia during each week.
Secondary	Weekly global assessment of change in dyspepsia condition.
Secondary	Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
Secondary	Quality of life at end of treatment compared to baseline.
Secondary	Safety and tolerability.

External Links

•   Results for CHTF919D2302 from the Novartis Clinical Trials website