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Constipation clinical trials

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NCT ID: NCT02946580 Terminated - Constipation Clinical Trials

Naloxegol for the Prevention of Constipation in Postoperative Spinal Surgery Patients

Start date: January 2017
Phase: Phase 4
Study type: Interventional

Constipation is a known complication of the postoperative period after spinal surgery, where prescription pain medicines called opioids are traditionally used in high doses for the treatment of surgery-related pain. The goal of this study is to determine the effectiveness of Movantik (naloxegol)—a FDA-approved drug used to treat constipation that is caused by opioids—in preventing constipation in patients undergoing spinal fusion surgery at MGH.

NCT ID: NCT02839889 Terminated - Pain Clinical Trials

Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)

Start date: September 2016
Phase: Phase 4
Study type: Interventional

The 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.

NCT ID: NCT02837783 Terminated - Clinical trials for Irritable Bowel Syndrome Characterized by Constipation

A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

Start date: December 21, 2016
Phase: Phase 4
Study type: Interventional

The 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.

NCT ID: NCT02829047 Terminated - Constipation Clinical Trials

Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration

Start date: August 2016
Phase: N/A
Study type: Interventional

The study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation. One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2 days, followed by one day without, one per day for 2 days followed by one day without, etc. (14 capsules in 3 weeks). The study will have one interim analysis. Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks. Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation. After 14 days the patients will return and eligibility will be re-assessed. Patients will be trained on how to use the base unit. Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period. Patients will receive phone calls up to twice per week and patient compliance will be monitored during the 8 weeks of the study.

NCT ID: NCT02813369 Terminated - Clinical trials for Opioid Induced Constipation

Naloxegol Health Outcome Post Authorisation Safety Study

Start date: September 2016
Phase:
Study type: Observational

This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity. This study is part of a broader post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in clinical practice.

NCT ID: NCT02745353 Terminated - Constipation Clinical Trials

Naloxegol in Cancer Opioid-Induced Constipation

Start date: May 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the effect of naloxegol versus the patient's usual care in treating opioid-induced constipation, as well as the effect on the patient's quality of life and how much pain is experienced. Also, the purpose of this study is to compare whether treatment with naloxegol versus usual care has any impact on the number of hospital or clinic visits or telephone calls to the patient's physician that are related to constipation, and to determine the patient's preference for continuing to receive naloxegol as treatment for opioid-induced constipation.

NCT ID: NCT02609607 Terminated - Multiple Sclerosis Clinical Trials

Treating Anorectal Dysfunction in MS

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The 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.

NCT ID: NCT02559817 Terminated - Clinical trials for Irritable Bowel Syndrome With Constipation

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

LIN-MD-63
Start date: November 1, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

NCT ID: NCT02239510 Terminated - Clinical trials for Chronic Idiopathic Constipation

Efficacy of Linaclotide to Senna for CIC

Start date: September 2014
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02144753 Terminated - Clinical trials for Constipation-predominant IBS (IBS-C)

Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)

Start date: March 2014
Phase: Phase 2
Study type: Interventional

The objective of this Phase II trial is to test the NTX-1 Fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. The investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e has less side effects) and is more effective than psyllium (the most commonly used fiber in the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA levels.