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Tegaserod

Phase 4

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

Tegaserod development status

Highest phase Phase 4 (NCT00348634)
Phase scored for NVSPhase 3
Registered trials 22 across 3 sponsors since Aug 2005

Tegaserod target and mechanism

Molecular targetHTR4
Target classPartial Agonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials11
Total Enrollment6,000

FDA Designations

No designations recorded

Tegaserod clinical trials

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.
HeartburnUnlock 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.
DyspepsiaUnlock trial analytics
PHASE3COMPLETED
An Evaluation of the Efficacy and Safety of Tegaserod 6 mg Bid Given Orally to Chinese Patients With Chronic Constipation
ConstipationUnlock trial analytics
PHASE3COMPLETED
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
DyspepsiaUnlock trial analytics
PHASE3COMPLETED
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
DyspepsiaUnlock trial analytics
PHASE3COMPLETED
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
DyspepsiaUnlock trial analytics
PHASE3COMPLETED
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.
Chronic ConstipationUnlock 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)Unlock trial analytics
PHASE3COMPLETED
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
DyspepsiaUnlock 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)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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
TegaserodDRUG -
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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
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Frequently asked questions about Tegaserod

What is Tegaserod?

Tegaserod is a small molecule drug developed by Novartis AG (ticker NVS) for gastrointestinal conditions. It has been studied in chronic constipation, constipation, dyspepsia, gastroesophageal reflux disease (GERD), heartburn, and symptomatic gastroesophageal reflux disease. It is a partial agonist of the HTR4 receptor and has been evaluated in Phase 3 clinical trials.

What is Tegaserod used for?

Tegaserod has been studied for chronic constipation, constipation, dyspepsia, gastroesophageal reflux disease (GERD), heartburn, and symptomatic gastroesophageal reflux disease. Its clinical trial program focused on dyspepsia in women. It is an investigational small molecule developed by Novartis AG for gastrointestinal disorders.

What does Tegaserod target?

Tegaserod targets HTR4, also known as the serotonin 5-HT4 receptor, where it acts as a partial agonist. This receptor activity is the basis for its investigation in gastrointestinal motility and functional bowel disorders such as chronic constipation and dyspepsia.

Who makes Tegaserod?

Tegaserod is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 3 clinical trial program evaluating Tegaserod in women with dyspepsia and other gastrointestinal conditions.

What phase is Tegaserod in?

Tegaserod is in Phase 3 clinical development. Five Phase 3 trials have been completed, with no active trials currently listed. The studies enrolled a total of 3,434 participants and evaluated Tegaserod in gastrointestinal conditions including dyspepsia, chronic constipation, and GERD.

What clinical trials is Tegaserod in?

Tegaserod has been evaluated in completed Phase 3 trials including NCT00232102, NCT00232089, NCT00232037, and NCT00232024. These studies assessed the efficacy and safety of Tegaserod versus placebo and long-term safety in women with dyspepsia, with enrollment ranging from 359 to 1,296 participants per trial.