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Trial · Interventional

Active, not recruitingPhase 4Registry data

Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
23 participants (actual)
Sponsor
Texas Tech University Health Sciences Center, El Paso · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
1 Sept 2015
Primary completion
Oct 2026 (estimated)
Completion
Jan 2027 (estimated)
First posted
18 Apr 2017
Last update posted
3 Apr 2026
Conditions
Chronic Constipation · Diabete Mellitus

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520202025
  1. Ph 4

    Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

    NCT03119584

    1 Sept 2015 to est. Jan 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • linaclotide or placeboDrug

Arms2

  • Active comparator

    1)28days of linaclotide or placebo

    patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.

  • Active comparator

    2)28days of linaclotide or placebo

    patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Improvement in frequency of bowel movements

    Time frame · Up to 10 weeks

    Registry description

    The primary outcome measure will indicate improvement in frequency of bowel movements (BMs) or not in a mean of available and recordered spontaneous BM (SBMs) over the 28 day treatment period compared to 28 days of placebo.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 period of screening through 14 days after study termination. * Loose or watery stools reported in the absence of laxatives for \>25% of BMs during the screening period by using Bristol Stool Form Scale (BSFS). * Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents) and chronic laxative use during the trial. * Patients diagnosed with severe, drug refractory gastroparesis (persistent daily vomiting), currently receiving parenteral feeding (N-G, J-G-Tubes), having history of frequent hospitalizations, or being implanted with gastric neurostimulation system. * Use of any of the following drugs within 3 days prior randomization and during the trial: a. Prokinetic agents (domperidone, metoclopramide, erythromycin). b. Medication containing opiates. c. Anti-spasmodic (e.g. Atropine, hyoscamine, scopolamine, glycopyrrolate). * Hemoglobin A1c\>8.2 * Use of illegal drugs. * Regular consumption of more than 2 drinks of alcohol per day * Chronic, more than 3/week use of NSAIDs. * Patients with prolonged straining/push during BMs suggesting severe pelvic floor dysfunction. * History or current diagnosis of diverticulitis and severe hemorrhoids. * History of gastric resections, partial colon resection, history of rectocele. * Existence of any major medical condition such as malignancy, severe renal and liver diseases, which in the decision of PI should be excluded from participation.

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