Zelnorm (Tegaserod Maleate) - Summary

ZELNORM SUMMARY

Zelnorm

Zelnorm® (tegaserod maleate) tablets contain tegaserod as the hydrogen maleate salt.

Zelnorm® (tegaserod maleate) is indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation.

The safety and effectiveness of Zelnorm in men with IBS with constipation have not been established.

Zelnorm® (tegaserod maleate) is indicated for the treatment of patients less than 65 years of age with chronic id-iopathic constipation. The effectiveness of Zelnorm in patients 65 years or older with chronic idiopathic constipation has not been established (see Geriatric Use).

The efficacy of Zelnorm for the treatment of IBS with constipation or chronic idiopathic constipation has not been studied beyond 12 weeks.

See all Zelnorm indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zelnorm (Tegaserod)

Irritable Bowel Syndrome (IBS) Symptoms, Diet, Treatment, and Test
Source: MedicineNet Chronic Pain Specialty [2017.09.22]
Title: Irritable Bowel Syndrome (IBS) Symptoms, Diet, Treatment, and Test
Category: Diseases and Conditions
Created: 2/25/2002 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

IBS-D (Irritable Bowel Syndrome with Diarrhea)
Source: MedicineNet Constipation Specialty [2017.09.22]
Title: IBS-D (Irritable Bowel Syndrome with Diarrhea)
Category: Diseases and Conditions
Created: 8/10/2016 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

Irritable Bowel Syndrome (IBS) Quiz: Test Your Medical IQ
Source: MedicineNet Laxatives For Constipation Specialty [2017.09.19]
Title: Irritable Bowel Syndrome (IBS) Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 10/12/2015 12:00:00 AM
Last Editorial Review: 9/19/2017 7:30:12 PM

Irritable Bowel Syndrome in Children (IBS)
Source: MedicineNet dicyclomine Specialty [2017.03.21]
Title: Irritable Bowel Syndrome in Children (IBS)
Category: Diseases and Conditions
Created: 6/24/2009 12:00:00 AM
Last Editorial Review: 3/21/2017 12:00:00 AM

Irritable Bowel Syndrome (IBS)
Source: MedicineNet alosetron Specialty [2017.03.16]
Title: Irritable Bowel Syndrome (IBS)
Category: Symptoms and Signs
Created: 10/16/2013 12:00:00 AM
Last Editorial Review: 3/16/2017 12:00:00 AM

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Published Studies Related to Zelnorm (Tegaserod)

Influence of tegaserod on proximal gastric tone and on the perception of gastric distention in functional dyspepsia. [2011.02]
BACKGROUND: Abnormalities in gastric sensorimotor function (hypersensitivity to distention and impaired meal accommodation) have been implicated in the pathophysiology of functional dyspepsia (FD).In the subgroup with normal gastric emptying, tegaserod 6 mg b.i.d enhanced gastric accommodation.

Long-term tegaserod treatment for dysmotility-like functional dyspepsia: results of two identical 1-year cohort studies. [2010.03]
BACKGROUND: Functional dyspepsia (FD) is a chronic disorder that adversely affects health-related quality of life (HRQoL). Published information on its long-term management is minimal and treatment options are limited. AIM: The aim of this study was to evaluate safety, efficacy and HRQoL with tegaserod 6 mg twice daily over 1 year in women with FD who completed one of two 6-week, randomized, placebo-controlled, double-blind studies... CONCLUSIONS: The long-term safety profile of tegaserod in women with FD was consistent with that of short-term treatment and accompanied by improvements in HRQoL, work productivity and symptom relief. These long-term results add to the clinical experience with FD and support the potential value of a 5-HT(4) agonist in the management of FD.

Long-term tegaserod treatment for dysmotility-like functional dyspepsia: results of two identical 1-year cohort studies. [2010]
6-week, randomized, placebo-controlled, double-blind studies... CONCLUSIONS: The long-term safety profile of tegaserod in women with FD was

A randomized, controlled, double-blind trial of the adjunct use of tegaserod in whole-dose or split-dose polyethylene glycol electrolyte solution for colonoscopy preparation. [2008.08]
BACKGROUND: Problems of compliance, quality, and safety of colon preparation regimens have prompted continued investigation with alternative forms of cleansing. OBJECTIVE: To evaluate the efficacy of tegaserod as an adjunct to a polyethylene glycol electrolyte solution (PEG-E), given as a whole dose or split dose, in colonoscopy preparation... CONCLUSIONS: Tegaserod has a marginal effect on the quality of colonoscopy preparation when used as an adjuvant to PEG-E. The split-dose PEG-E was superior to the whole-dose PEG-E and resulted in better colon cleansing, adherence, and tolerance.

Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials. [2008.08]
OBJECTIVES: Therapies for dysmotility-like functional dyspepsia (FD) are limited. We studied tegaserod, a selective serotonin type 4 receptor agonist, in patients with FD... CONCLUSIONS: Some improvement in dysmotility-like FD was observed with tegaserod treatment. The clinical implication of this improvement is uncertain.

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Clinical Trials Related to Zelnorm (Tegaserod)

A Treatment Investigational New Drug (tIND) Program of Tegaserod in Women With Irritable Bowel Syndrome With Constipation or With Chronic Idiopathic Constipation [No longer available]
To provide tegaserod to eligible women adult patients who did not have satisfactory improvement of their irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) symptoms with other available treatment(s) and / or patients who had satisfactory improvement of their symptoms with prior tegaserod treatment for IBS-C or CIC.

Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis [Terminated]
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.

The Effects of Tegaserod Vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia [Withdrawn]
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia

Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain. [Terminated]
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows: Patients on tegaserod 6 mg twice daily (b. i.d.) or 12 mg once daily (o. d.) in the core study will remain on the same dose in the extension (double-blind). Patients on placebo during the core study will receive tegaserod 12 mg o. d. (open-label) Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.

Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain. [Terminated]
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows: Patients will be randomly assigned to receive open label tegaserod 6 mg b. i.d. or tegaserod 12 mg o. d. using an allocation ratio of 1: 1. Patients who enter this study AFTER the core study interim analysis receive the treatment as follows: Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.

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