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Constipation clinical trials

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NCT ID: NCT00669461 Terminated - Parkinson's Disease Clinical Trials

Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Start date: June 2009
Phase: N/A
Study type: Interventional

Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following: 1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary) 2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary) 3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)

NCT ID: NCT00653887 Terminated - Constipation Clinical Trials

Biofeedback and Cortical Excitability

Biofeedback
Start date: January 2008
Phase: N/A
Study type: Interventional

Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.

NCT ID: NCT00607971 Terminated - Clinical trials for Constipation-Predominant Irritable Bowel Syndrome

Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Start date: April 2006
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).

NCT ID: NCT00577499 Terminated - Cystic Fibrosis Clinical Trials

Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis

Start date: October 2007
Phase: N/A
Study type: Observational

Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency, and achieving and maintaining adequate nutrition is an important goal of therapy because it is positively correlated with lung function. Lubiprostone activates chloride channels in the GI tract. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. This project is an observational study to examine the effects of lubiprostone on nutritional status and lung function in adults with CF. Our hypothesis is that lubiprostone will have beneficial effects on nutritional status.

NCT ID: NCT00563758 Terminated - Constipation Clinical Trials

A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy, Safety and Tolerability of Tegaserod 2 mg Bid vs Placebo in Patients With Chronic Constipation

Start date: December 2004
Phase: N/A
Study type: Interventional

Idiopathic or functional constipation is a common disorder, affecting up to 20% of the population depending on demographic factors, the sampling situation and the definitions used. Constipation is a symptom of many diseases and is a collective term, used by the patient to imply that stools are too hard, too infrequent or too difficult to pass. A recent survey conducted in Hong Kong showed a prevalence of 14% according to the Rome criteria. Based on an epidemiological study in US, there were 2.5 million annual physician visits for this problem. Exact epidemiological data however are lacking, mainly because of the difference between self-reported constipation and scientifically defined constipation. Treatment of constipation is usually based on increased dietary fiber and supplementation with bulking agents, exercise, and habit training. However, often only partial relief is obtained, and the majority of patients use non-bulking laxatives on a regular basis without medical supervision. Chronic use of non-bulking laxatives is often inappropriate3, and may lead to side effects such as dependency and progressive tolerance, electrolyte imbalance, and, for the anthraquinones, melanosis coli. In addition, stimulant laxatives may damage the myenteric plexus4, resulting in cathartic colon5. A more appropriate approach to the therapy of constipation consists of physiologically stimulating intestinal motility. Tegaserod, an aminoguanidine indole compound, is a representative of a new class of 5-HT4 agonists, with regard to both chemistry and pharmacology. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves resulting in increased contractility and stimulation of the peristaltic reflex. In animal models, tegaserod acts as a motility-enhancing agent, exerting activity throughout the gastrointestinal tract11. Tegaserod has also been shown to significantly accelerate bowel transit in healthy volunteers and in patients with constipation-predominant irritable bowel syndrome (C-IBS). Based on the pharmacodynamic properties, tegaserod is a promotile compound suitable for the treatment associated with small and/or large bowel dysfunction e.g. constipation. From phase III adequate and well-controlled studies in patients with C-IBS it has been shown that tegaserod was effective in relieving symptoms of C-IBS. The effect was seen as early as the first week of treatment with sustained effects over 12 weeks. Both tegaserod 4 mg/d (2 mg bid) and 12 mg/d (6 mg bid) significantly increased bowel frequency and decreased stool consistency. It is proposed to test both doses for the phase III program in chronic constipation. The aim of this study is to demonstrate the effect of tegaserod on bowel habits in patients suffering from chronic idiopathic constipation.

NCT ID: NCT00536523 Terminated - Ovarian Cancer Clinical Trials

Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Start date: April 2007
Phase: N/A
Study type: Observational

RATIONALE: Gathering information about changes in serotonin levels in patients undergoing chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help doctors learn more about constipation caused by chemotherapy. PURPOSE: This clinical trial is studying how blood levels of serotonin effect constipation caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

NCT ID: NCT00501241 Terminated - Clinical trials for Chronic Constipation

Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation

Start date: July 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.

NCT ID: NCT00467350 Terminated - Constipation Clinical Trials

Comparison Trial of Enema vs. PEG 3350 for Constipation

Start date: December 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.

NCT ID: NCT00414024 Terminated - Clinical trials for Opioid-induced Constipation

Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

Start date: February 2007
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00399659 Terminated - Clinical trials for Opioid-induced Constipation

Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

Start date: November 2006
Phase: Phase 3
Study type: Interventional

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.