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Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119584
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Constipation Diabete Mellitus Drug: linaclotide or placebo Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : January 30, 2021


Arm Intervention/treatment
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.
Drug: linaclotide or placebo
Other Name: Linzess

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.
Drug: linaclotide or placebo
Other Name: Linzess




Primary Outcome Measures :
  1. Improvement in frequency of bowel movements [ Time Frame: Up to 10 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119584


Locations
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United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
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Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center- El Paso, Texas
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Responsible Party: Irene Sarosiek, Professor of Medicine, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03119584    
Other Study ID Numbers: E15025
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso:
chronic constipation
diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Constipation
Signs and Symptoms, Digestive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linaclotide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents