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NCT01746043 · ClinicalTrials.gov registry record · Phase 2

A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT01746043: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01746043 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01746043, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness). Armodafinil is designed to prevent excessive sleepiness. Minocycline is an antibiotic, which may help to reduce multiple symptoms. In this study, you may receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Primary Outcome

Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores

Interventions

  • OTHER Placebo
  • BEHAVIORAL Questionnaires
  • DRUG Minocycline
  • DRUG Armodafinil

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2013-02
Est. Completion 2017-01
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01746043 record still lists

NCT01746043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01746043 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01746043 about?

NCT01746043 is a clinical study titled "A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer". The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness). A...

What is the current status of trial NCT01746043?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2013-02. Estimated completion is 2017-01.

What interventions are being tested in trial NCT01746043?

The interventions under investigation include: Placebo (OTHER), Questionnaires (BEHAVIORAL), Minocycline (DRUG), Armodafinil (DRUG).

Who is sponsoring clinical trial NCT01746043?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01746043's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 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 NCT01746043, the US trial registry maintained by the National Library of Medicine. NCT01746043 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.