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NCT00016653 · ClinicalTrials.gov registry record · Phase 2

Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy

A Phase 2 study, sponsored by Cooperative International Neuromuscular Research Group.

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT00016653 is a Phase 2 study that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 48 participants.

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The verdict

NCT00016653, a Phase 2 study, has completed, sponsored by Cooperative International Neuromuscular Research Group.

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

This study will help to determine the effectiveness of glutamine and creatine as a possible therapy for DMD. Boys with DMD who are enrolled in this trial will be randomly chosen to receive creatine monohydrate or glutamine or an inactive placebo orally for six months. Once a month during the six-month treatment period, the study participants will have their muscle strength evaluated using manual and computerized testing methods. This study will be conducted at several CINRG Centers throughout the U.S., Belgium, Israel and Puerto Rico. This study is supported by the Muscular Dystrophy Association.

Interventions

  • DRUG Glutamine
  • DRUG Creatine Monohydrate

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2000-06
Est. Completion 2006-12
Phase Phase 2

What the Registry Record Tells You About NCT00016653

The ClinicalTrials.gov registry entry for NCT00016653 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cooperative International Neuromuscular Research Group, which has 13 total studies on file at ClinicalTrials.gov.

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

NCT00016653 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00016653 about?

NCT00016653 is a clinical study titled "Creatine and Glutamine in Steroid-Naive Duchenne Muscular Dystrophy". This study will help to determine the effectiveness of glutamine and creatine as a possible therapy for DMD. Boys with DMD who are enrolled in this trial will be randomly chosen to receive creatine monohydrate or glutamine or an inactive placebo orally for six months. Once a month during the six-mon...

What is the current status of trial NCT00016653?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2000-06. Estimated completion is 2006-12.

What interventions are being tested in trial NCT00016653?

The interventions under investigation include: Glutamine (DRUG), Creatine Monohydrate (DRUG).

Who is sponsoring clinical trial NCT00016653?

This trial is sponsored by Cooperative International Neuromuscular Research Group, which has 13 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.