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NCT00124709 · ClinicalTrials.gov registry record · Phase 4

Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

A Phase 4 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 4
Development phase
1,091
Enrollment target

NCT00124709 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 1,091 participants.

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The verdict

NCT00124709, a Phase 4 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 4
Development phase
1,091 participants
Enrollment target

Study Summary

This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Interventions

  • DRUG Corticosteroid
  • DRUG Pimecrolimus

Trial Details

FieldValue
Enrollment Target 1,091 participants
Start Date 2003-10
Est. Completion 2008-11
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00124709

The ClinicalTrials.gov registry entry for NCT00124709 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1,091 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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

NCT00124709 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00124709 about?

NCT00124709 is a clinical study titled "Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification". This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all ...

What is the current status of trial NCT00124709?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1,091 participants. The study started on 2003-10. Estimated completion is 2008-11.

What interventions are being tested in trial NCT00124709?

The interventions under investigation include: Corticosteroid (DRUG), Pimecrolimus (DRUG).

Who is sponsoring clinical trial NCT00124709?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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

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.