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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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