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 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.
Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced...
ConstipationPainThe primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain...
ConstipationThis study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
Chronic ConstipationThis study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
Efficacy and Safety of SYN-010 in IBS-C
Irritable Bowel Syndrome With ConstipationIrritable bowel syndrome (IBS) is a gastrointestinal (GI) syndrome characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. The symptoms of IBS not only adversely affect a patient's health-related quality of life (QoL), but also place a significant financial burden on society due to reduced work productivity and increased use of healthcare-related resources. Patients with IBS frequently complain of abdominal bloating and increased gas production in the form of flatulence or belching. The prevalence in North America and Europe is approximately 10-15%. Irritable bowel syndrome affects all ages and genders however there is a 2:1 female predominance in North America. Irritable bowel syndrome is classified into 4 subtypes based on stool pattern: IBS with constipation (IBS-C), IBS with diarrhea, mixed IBS, and un-subtyped IBS. Irritable bowel syndrome with constipation is defined as the presence of hard or lumpy stools with ≥ 25 percent of bowel movements and loose or watery stools with < 25% of bowel movements. SYN-010 is a modified release, oral formulation of lovastatin being developed for the treatment of IBS-C. The SYN-010 program is based predominantly on research by Dr. Mark Pimentel and collaborators hypothesizing that reduction in intestinal methane (methane) production can reverse constipation and improve global symptoms in IBS-C. Methane production in humans is due to methanogenic archaea in the intestine, predominantly Methanobrevibacter smithii (M. smithii). Methane, the key product of anaerobic respiration of methanogens, had been perceived to produce no ill effects in humans aside from gaseous distention. However, several research groups worldwide have shown that a significant percentage of patients with IBS-C excrete methane, and elevated methane production by methanogens correlates with constipation and related symptoms in both IBS-C and chronic idiopathic constipation. A direct causative role for methane in IBS-C was demonstrated in a recent case report, wherein a woman undergoing fecal microbiota transplantation (FMT) for C. difficile infection unknowingly received stool containing a high concentration of methanogens. The FMT recipient rapidly developed severe symptoms of IBS-C that were subsequently reversed by ablation of methane production.
Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
Functional ConstipationThe aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Opioid-Induced ConstipationThe purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation...
Non-cancer PainOpioid Induced ConstipationThe study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.
Domperidone for Relief of Gastrointestinal Disorders
GastroparesisGERD5 moreThe purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.
Lubiprostone as a Treatment for Constipation in Parkinson's Disease
ConstipationParkinson's DiseaseDelayed 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: Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary) Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary) Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)