Recent Updates
Recently added Catalysts

Tegaserod

Phase 3

Chronic Constipation | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Nov 18, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment1,026

FDA Designations

No designations recorded

Clinical trial landscape

Tegaserod · 11 trials · 6 indications

Phase 3 10Phase 2 1
NCT00171457The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.Heartburn
COMPLETED24 Analytics
NCT00171470The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.Dyspepsia
COMPLETED60 Analytics
NCT00139568An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic ConstipationConstipation
COMPLETED600 Analytics
NCT00232037Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of DyspepsiaDyspepsia
COMPLETED359 Analytics
NCT00232102Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of DyspepsiaDyspepsia
COMPLETED423 Analytics
NCT00232089Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaDyspepsia
COMPLETED1,296 Analytics
NCT00141089Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.Chronic Constipation
COMPLETED1,026 Analytics
NCT00171483Assessment 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).Gastroesophageal Reflux Disease (GERD)
COMPLETED30 Analytics
NCT00232024Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaDyspepsia
COMPLETED1,296 Analytics
NCT00171418Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).Gastroesophageal Reflux Disease (GERD)
COMPLETED54 Analytics
PHASE3COMPLETED
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
Heartburn
NCT0017145724
Unlock trial analytics
PHASE3COMPLETED
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
Dyspepsia
NCT0017147060
Unlock trial analytics
PHASE3COMPLETED
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
Constipation
NCT00139568600
Unlock trial analytics
PHASE3COMPLETED
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Dyspepsia
NCT00232037359
Unlock trial analytics
PHASE3COMPLETED
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Dyspepsia
NCT00232102423
Unlock trial analytics
PHASE3COMPLETED
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Dyspepsia
NCT002320891,296
Unlock trial analytics
PHASE3COMPLETED
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Chronic Constipation
NCT001410891,026
Unlock trial analytics
PHASE3COMPLETED
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).
Gastroesophageal Reflux Disease (GERD)
NCT0017148330
Unlock trial analytics
PHASE3COMPLETED
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Dyspepsia
NCT002320241,296
Unlock trial analytics
PHASE3COMPLETED
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Gastroesophageal Reflux Disease (GERD)
NCT0017141854
Unlock trial analytics

Study Endpoints

Primary Endpoints

To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)
Change from baseline in number of complete spontaneous bowel movements (CSBM) per week
Long term safety at 6 months.
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)
Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline.
To determine the effect of 6 weeks of tegaserod in addition to proton pump inhibitors on heartburn and regurgitation (weekly assessment)
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)
To determine the effect of 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions.
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
Decreasing frequency of regurgitation during week 4 of treatment
Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone

Secondary Endpoints

1) Comparing effects at end of treatment compared to baseline:
To verify that tegaserod modulates esophageal sensitivity to esophageal distention
To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
TegaserodDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female subjects at least 18 years of age. * Subjects willing to undergo multiple nasogastric intubations. * Patients with functional heartburn will need to meet ROME II criteria. * Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characteriz...

Countries:United StatesSwitzerland
Unlock Eligibility Criteria

Frequently asked questions about Tegaserod

What is Tegaserod used for?

Tegaserod is an investigational small molecule being developed for gastrointestinal conditions including dyspepsia, heartburn, constipation, symptomatic gastroesophageal reflux disease, chronic constipation, and gastroesophageal reflux disease (GERD). It is being studied in clinical trials for these indications, though it is not approved and remains in clinical development.

Who makes Tegaserod?

Tegaserod is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety for various gastrointestinal conditions.

What phase is Tegaserod in?

Tegaserod is in Phase 3 clinical development for chronic constipation and gastroesophageal reflux disease (GERD). It has completed multiple clinical trials, including Phase 2 and Phase 3 studies, but it is not approved and remains investigational.

What clinical trials is Tegaserod in?

Tegaserod has completed five clinical trials, including NCT00139568 for chronic constipation, NCT00149851 for symptomatic gastroesophageal reflux disease, and NCT00171418 and NCT00171483 for GERD with incomplete response to proton pump inhibitors. All trials are completed, with no active trials ongoing.

Is Tegaserod the same as Zelnorm?

Tegaserod is also known by the brand name Zelnorm. It is being studied for gastrointestinal conditions such as chronic constipation and GERD, and is currently in clinical development by Novartis AG.