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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00232089
• Collaborator: (none)
• Enrollment: 1,296
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 51.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia	Drug: Tegaserod	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Weekly assessment of satisfactory relief of dyspepsia. []

2. Daily assessment of percentage of patients responding on average severity score. []

3. For each week assessment of average daily severity score. []

4. Percentage of days with satisfactory relief of dyspepsia during each week. []

5. Weekly global assessment of change in dyspepsia condition. []

6. Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. []

7. Quality of life at end of treatment compared to baseline. []

8. Safety and tolerability. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis	East Hanover	New Jersey	United States	07936-108

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, East Hanover NJ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00232089
• Other Study ID Numbers: CHTF919D2302
• First Posted: Oct 4, 2005
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by , ,: Dyspepsia, gastrointestinal, tegaserod
• Additional relevant MeSH terms: Dyspepsia; Tegaserod

Study Results

No Results Posted as of Nov 18, 2016