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OpenTrials
Completed

NCT Number: NCT00171483

Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .

Completed

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consultants for Clinical Research of South Florida, Boynton Beach, Florida, United States

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Heartburn for at least 3 days in the week prior to screening
  • Regurgitation for at least 3 days in the week prior to screening
  • Stable dose PPI therapy > 4 weeks
  • Incomplete relief on daily PPI therapy > 4 weeks

Exclusion criteria

  • Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
  • Previous gastrointestinal surgery that may influence esophageal motor function
  • Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Tegaserod

Drug

Primary outcomes

  1. To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)

Secondary outcomes

  1. To evaluate the sensitivity of three global symptom assessments of GERD related to complaints (end of treatment compared to baseline)

  2. To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)

  3. To assess baseline characteristics that may predict a positive response to tegaserod add-on therapy in GERD patients

  4. To assess patient satisfaction with treatment (end of treatment)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Jan 28, 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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