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NCT01055704 · ClinicalTrials.gov registry record · Phase 4
Effect of Methylnaltrexone on GI Transit in Healthy Volunteers
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT01055704: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT01055704 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01055704, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids in healthy human subjects. The hypotheses are: 1. Methylnaltrexone administered subcutaneously enhances gastrointestinal motility with acceleration of overall colonic transit, and ascending colon emptying of solids in healthy humans. 2. Methylnaltrexone significantly accelerates colonic transit that is delayed by codeine
Primary Outcome
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Interventions
- DRUG Methylnaltrexone only
- DRUG Codeine only
- DRUG Methylnaltrexone + codeine
- DRUG Placebo + placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-02 |
| Phase | Phase 4 |
What the finished NCT01055704 record still lists
NCT01055704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 4 interventions - of which Methylnaltrexone only is the first listed.
NCT01055704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01055704 about?
NCT01055704 is a clinical study titled "Effect of Methylnaltrexone on GI Transit in Healthy Volunteers". This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids in healthy human subjects. The hypotheses are: 1. Methylnaltrexone a...
What is the current status of trial NCT01055704?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2009-11. Estimated completion is 2010-02.
What interventions are being tested in trial NCT01055704?
The interventions under investigation include: Methylnaltrexone only (DRUG), Codeine only (DRUG), Methylnaltrexone + codeine (DRUG), Placebo + placebo (DRUG).
Who is sponsoring clinical trial NCT01055704?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01055704's enrollment target sits among peer trials
48 1331st of 2000 higher than 653 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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