41 Clinical Trials for Various Conditions
This is a randomized, double blind, placebo controlled trial to evaluate the tolerability of MHS 1031. Tolerability will be assessed using the change in complete spontaneous bowel movements (CSBM), PRO questionnaires, concomitant medication assessments, and assessment of adverse events, from baseline (determined during Screening Phase) to Week 8 (Day 56). The primary analysis will be conducted to assess the tolerability of MHS 1031 product and of the formulated placebo in randomized subjects with CIC diagnosed according to a modified Rome IV criteria.
The was performed to assess the safety and efficacy of the vibrant capsule vs. placebo for the treatment of subjects with functional Constipation.
The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to \< 18 years diagnosed with Chronic Idiopathic Constipation.
Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).
The primary objective of this study is to assess the potential of LINZESS® (linaclotide) treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) participants and to evaluate lower doses of linaclotide.
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with \<3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period. The objectives of this study are: * To assess the efficacy of YKP10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation. * To determine the safety and tolerability of YKP10811 once daily in subjects with chronic idiopathic constipation.
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)
12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.
Efficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.
The objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation
This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with chronic idiopathic constipation.
The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride. The main aim of the study is to learn if any medical problems in pregnant women or their infants might be related to taking prucalopride during pregnancy. Participants are not required to take prucalopride during the study. The study is non-interventional. Women and their infants are followed during pregnancy and for 1 year after pregnancy to collect information on maternal, pregnancy, and infant outcomes. During the study, participants will be asked questions during 3 telephone interviews; 2 during pregnancy and 1 just after their expected delivery date. Participants who took or are taking prucalopride will be asked more detailed questions about this during these interviews. All information is collected remotely, and no visits to the study site are required. Also, all participants will be asked to complete a questionnaire about their baby when their baby is about 1 year old.
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects. During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory. Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby.
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.
This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects.
In 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.
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
The purpose of this study is to determine if lubiprostone may change the rate of movement of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI) tract is slower due to constipation. To be able to measure the time difference in the duration of transit of the FDA approved SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to lubiprostone. The investigators anticipate to capture the possibility to reduce/eliminate the small intestinal bacterial overgrowth in chronically constipated patients after administration of study drug- lubiprostone.