Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

Status Active, not recruiting

Clinical Trial Summary

Study includes 5 visits, when all basic clinical information, vital signs, symptoms, and side effects are going to be assessed at each appointment. Patients are going to be assigned by the computer, to receive an active or non-active drug for 14 days in a first phase. The order will be change during the second phase. The 2 weeks break without our medication will separate these phases. A very close observation regarding safety of our subjects will be implemented by study personnel and clinical investigators.

Clinical Trial Description

The symptoms of chronic constipation are defined as infrequent bowel movements, hard stool, straining during defecation, bloating, abdominal discomfort, and sensation of incomplete evacuation. Constipation has been reported as a common complication of diabetic neuropathy. A new medication, called linaclotide, was studied on many patients, and it is approved to be on a market for constipated patients. Unfortunately diabetics were not included in these previous studies; hence we designed the project which is going to address the possible benefit of this drug in diabetic population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03119584
Study type	Interventional
Source	Texas Tech University Health Sciences Center, El Paso
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	September 1, 2015
Completion date	January 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05980988` - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation	N/A
Recruiting	`NCT03819062` - Sacral Neuromodulation as Treatment for Chronic Constipation	N/A
Completed	`NCT00765882` - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation	Phase 3
Completed	`NCT00730171` - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT00354575` - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units	Phase 2
Completed	`NCT00765999` - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT01793753` - Effect of Propofol on Internal Anal Sphincter Pressure During ARM	N/A
Completed	`NCT00746200` - Acupuncture for Chronic Constipation	Phase 3
Enrolling by invitation	`NCT00671684` - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease	Phase 1/Phase 2
Completed	`NCT00391820` - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)	Phase 2
Completed	`NCT00404040` - Movicol in Childhood Constipation (ProMotion Study)	Phase 2
Completed	`NCT02281630` - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)	Phase 2
Completed	`NCT00256984` - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)	Phase 4
Recruiting	`NCT05192317` - Administration of a Natural Molecular Complex in Functional Chronic Constipation	N/A
Active, not recruiting	`NCT05202028` - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy	N/A
Completed	`NCT05734859` - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation	N/A
Completed	`NCT01007123` - Study of A3309 in Patients With Chronic Idiopathic Constipation	Phase 2
Completed	`NCT00402337` - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation	Phase 2
Completed	`NCT02961556` - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation	Phase 3
Recruiting	`NCT04869280` - Post-Marketing Study of Prucalopride Safety In Pregnancy