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NCT03119584 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
A Phase 4 study, sponsored by Texas Tech University Health Sciences Center, El Paso.
- Active
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT03119584: Active Phase 4 study, sponsored by Texas Tech University Health Sciences Center, El Paso.
NCT03119584 is a Phase 4 study that is active but no longer recruiting, run by Texas Tech University Health Sciences Center, El Paso. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03119584, a Phase 4 study, is active but no longer recruiting, sponsored by Texas Tech University Health Sciences Center, El Paso.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG linaclotide or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-09-01 |
| Est. Completion | 2027-01 |
| Phase | Phase 4 |
What the registry record for NCT03119584 still lists
NCT03119584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which linaclotide or placebo is the first listed.
NCT03119584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03119584 about?
NCT03119584 is a clinical study titled "Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation". 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 durin...
What is the current status of trial NCT03119584?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2015-09-01. Estimated completion is 2027-01.
What interventions are being tested in trial NCT03119584?
The interventions under investigation include: linaclotide or placebo (DRUG).
Who is sponsoring clinical trial NCT03119584?
This trial is sponsored by Texas Tech University Health Sciences Center, El Paso, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03119584's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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