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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.


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NEWS HIGHLIGHTS

Media Articles Related to Zelnorm (Tegaserod)

Zelnorm Has Serious Side Effects Alert
Source: MedicineNet tegaserod Specialty [2007.04.02]
Title: Zelnorm Has Serious Side Effects Alert
Category: Health News
Created: 4/29/2004
Last Editorial Review: 4/2/2007

Lexicon Announces Positive Phase 2 Results Of LX1031 In Non-Constipating Irritable Bowel Syndrome
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.11.13]
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that the company's investigational new drug, LX1031, a tryptophan hydroxylase (TPH) inhibitor, demonstrated positive results in clinically important parameters for the treatment of non-constipating irritable bowel syndrome (IBS).

Pharmos Announces Results Of Phase 2b Irritable Bowel Syndrome Study
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.09.15]
Pharmos Corporation (Pink Sheets: PARS) announced the results of its Phase 2b Dextofisopam clinical trial to evaluate safety and efficacy of the compound in irritable bowel syndrome. Although the primary efficacy variable (% of weeks responding for adequate overall relief of IBS symptoms) did not reach statistical significance, the percentage responding for the Dextofisopam 200 mg group was higher than that observed for the Phase 2a trial.

Contrary To Insoluble Fiber, Soluble Fiber Is An Effective Treatment For Irritable Bowel Syndrome
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.08.28]
The first trial in increasing dietary fiber in a primary care setting is published on bmj.com today. It reports that soluble fiber (psyllium) is an effective treatment for irritable bowel syndrome (IBS). On the other hand, insoluble fiber such as bran may worsen symptoms. Irritable bowel syndrome is characterized by abdominal pain and an irregular bowel habit. It affects about 10 percent of the population.

Alternative Treatment For Irritable Bowel Syndrome When Conventional Therapy Has Failed
Source: Irritable-Bowel Syndrome News From Medical News Today [2009.08.13]
IBS remains a common intestinal disorder causing significant discomfort and poor quality of life in patients who have the diagnosis. TCAs have been shown to improve abdominal pain in patients with IBS; however, there is insufficient evidence of global symptom relief. The search for an optimal treatment to improve symptoms and quality of life in IBS remains ongoing. A research article published in the World Journal of Gastroenterology addresses this problem.

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Published Studies Related to Zelnorm (Tegaserod)

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.

Tegaserod Treatment for Dysmotility-Like Functional Dyspepsia: Results of Two Randomized, Controlled Trials. [2008.06.23]
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.

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. [2008.05.27]
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 for female patients suffering from IBS with mixed bowel habits or constipation: a randomized controlled trial. [2008.05]
OBJECTIVES: Though the greatest proportion of irritable bowel syndrome (IBS) patients report a mixed bowel pattern (IBS-Mixed), no available therapies have been rigorously evaluated in this subgroup. This study aimed to evaluate the efficacy and safety of the 5-HT(4) agonist tegaserod in women with IBS-Mixed and IBS with constipation (IBS-C)... CONCLUSIONS: Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and IBS-C.

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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.

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.

The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia. [Completed]

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

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Page last updated: 2009-11-13

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