Trial · Interventional
Active, not recruitingPhase 4Registry dataEfficacy 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
- Ph 4
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
NCT031195841 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.
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
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