A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy, Safety...
ConstipationChronic DiseaseIdiopathic 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.
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain....
Opioid-induced ConstipationThis 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.
Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With...
CancerConstipationThis study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.
Efficacy of Linaclotide to Senna for CIC
Chronic Idiopathic ConstipationIn this prospective, randomized, double blind study, the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and randomized to Senna or Linaclotide. Patients will be asked to complete questionnaires during the study and will be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures from surveys regarding bowel habits, relief, and satisfaction.
Treating Anorectal Dysfunction in MS
ConstipationFecal Incontinence1 moreThe investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10 mg rectal suppository every other day improves bowel-related symptoms in patients with multiple sclerosis. Patients will be randomized to receive either a placebo suppository or bisacodyl suppository dosed every other day for 4 weeks.
Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced...
CancerConstipation1 moreThe purpose of this study is to determine if naloxegol can be used in the treatment of opioid-induced constipation in patients with cancer and pain. This phase 4 study consists of a two week randomized double blind period followed by a two week open-label period.
Naloxegol US PMR CV Safety.
Opioid Induced ConstipationThe overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome...
Irritable Bowel Syndrome Characterized by ConstipationThe objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.
Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders
IBS - Irritable Bowel SyndromeConstipationThe purpose of this study is study bowel symptoms, quality of life, and personal factors that may affect your health. In Aim 1 of this study participants will be invited to complete 6 survey-based questionnaires online. In Aim 2 of this study will monitor the effectiveness of a 12 week therapy program on bowel symptoms and overall quality of life.
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related...
Opioid-Induced ConstipationThe purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR). The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).