Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation (NCT03119584) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
United States23 participantsStarted 2015-09-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type II diabetics.
* Functional Constipation defined by Rome III criteria are as follows: a. At least a 6 months history of constipation.
b. Less than three spontaneous bowel movements (SBMs) per week. c. At least 25% of stools are lumpy or hard stools as it is described in Bristol Stool Form Scale (BSFS) less than score of 6.
d. Sensation of incomplete evacuation following at least 25% of bowel movements.
e. Straining on at least 25% of defecations. f. Sensation of anorectal obstruction/blockage for at least 25% of defecations.
Note: The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study.
* For patients' ≥ 50 years of age, normal colonic anatomy as documented by colonoscopy or double-contrast barium enema, performed within the previous 5 years, based on the American Gastroenterological Association guidelines.
* Patients with confirm diagnosis of Diabetic Autonomic Neuropathy based on results of ANX 3.0, real-time ANS monitoring system will be included in this investigation.
* Patients diagnosed with diabetic peripheral neuropathy and/or symptoms of functional gastroduodenal disorders, such as GERD and functional dyspepsia may participate in a study.
Exclusion Criteria:
* Pregnancy or lactation
* Subjects unwilling to practice adequate contraception throughout the perio…
What they're measuring
1
Improvement in frequency of bowel movements
Timeframe: Up to 10 weeks
Trial details
NCT IDNCT03119584
SponsorTexas Tech University Health Sciences Center, El Paso