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Completed

NCT Number: NCT00232024

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

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.

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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis

East Hanover, New Jersey, 07936-108, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, 18 years or 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 upper GI endoscopy findings such as esophageal, gastric erosions or ulcers and/or duodenal ulcers/erosions.
  • Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting.

Other protocol-defined inclusion/exclusion criteria may appl

Treatment and study plan

Tegaserod

Drug

Primary outcomes

  1. Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)

Secondary outcomes

  1. Average severity score during each week.

  2. Percentage of days with satisfactory relief of dyspepsia during each week.

  3. Weekly global assessment of change in dyspepsia condition.

  4. Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.

  5. Quality of life at end of treatment compared to baseline.

  6. Safety and tolerability.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Feb 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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