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NCT01345175 · ClinicalTrials.gov registry record · Phase 3

Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer

A Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 3
Development phase
69
Enrollment target

NCT01345175: Completed Phase 3 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01345175 is a Phase 3 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 69 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01345175, a Phase 3 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 3
Development phase
69 participants
Enrollment target

Study Summary

The most common long-term problems after rectal surgery are bowel problems. These problems can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully clear your bowels, and/or poor control of gas and stool. The investigators believe that a major cause of these problems is too much bacteria in the bowel and treatment with antibiotic tablets will hopefully help improve these bowel problems. In order to test this idea, the Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring a clinical trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that has no effect) in the treatment of these bowel problems. Following this we will attempt to see if another antibiotic metronidazole also helps to treat these bowel problems. Both Metronidazole and rifaximin are well established drugs that have minimal side effects.

Interventions

  • DRUG Placebo
  • DRUG Rifaximin

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2011-04-26
Est. Completion 2023-03-23
Phase Phase 3
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT01345175 record still lists

NCT01345175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

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

NCT01345175 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01345175 about?

NCT01345175 is a clinical study titled "Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer". The most common long-term problems after rectal surgery are bowel problems. These problems can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully clear your bowels, and/or poor control of gas and stool. The investigators believe that a major cause of these probl...

What is the current status of trial NCT01345175?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2011-04-26. Estimated completion is 2023-03-23.

What interventions are being tested in trial NCT01345175?

The interventions under investigation include: Placebo (DRUG), Rifaximin (DRUG).

Who is sponsoring clinical trial NCT01345175?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01345175's enrollment target sits among peer trials

69 1793rd of 2000 higher than 205 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01345175, the US trial registry maintained by the National Library of Medicine. NCT01345175 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.