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NCT01038687 · ClinicalTrials.gov registry record · Phase 2

Effect of Ileal Bile Acid Transporter Inhibitor in Functional Constipation

A Phase 2 study, sponsored by Michael Camilleri, MD.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target

NCT01038687: Completed Phase 2 study, sponsored by Michael Camilleri, MD.

NCT01038687 is a Phase 2 study that has completed, run by Michael Camilleri, MD. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01038687, a Phase 2 study, has completed, sponsored by Michael Camilleri, MD.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation.

Primary Outcome

Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Colonic transit was measured by quantification of radioactive counts via abdominal scintiscans. Overall colonic transit was computed as the colonic geometric center (GC), which is the weighted average of counts in the different colonic regions (ascending, transverse, descending, rectosigmoid and stool), r

Interventions

  • DRUG placebo
  • DRUG A3309

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2010-01
Est. Completion 2011-01
Phase Phase 2
Michael Camilleri, MD

3 total trials

What the finished NCT01038687 record still lists

NCT01038687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01038687 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01038687 about?

NCT01038687 is a clinical study titled "Effect of Ileal Bile Acid Transporter Inhibitor in Functional Constipation". This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation.

What is the current status of trial NCT01038687?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-01. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01038687?

The interventions under investigation include: placebo (DRUG), A3309 (DRUG).

Who is sponsoring clinical trial NCT01038687?

This trial is sponsored by Michael Camilleri, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01038687's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01038687, the US trial registry maintained by the National Library of Medicine. NCT01038687 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.