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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: Clinical Trial Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00124709 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 1,091 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (111% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.
Interventions
- DRUG Corticosteroid
- DRUG Pimecrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,091 participants |
| Start Date | 2003-10 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
Why NCT00124709 stopped before completion
NCT00124709 is an interventional study that assigns participants to a tested intervention. Its 1,091 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (111% higher).
The record links to 0 conditions, and to 2 interventions - of which Corticosteroid is the first listed.
NCT00124709 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00124709's enrollment target sits among peer trials
1,091 66th of 2000 higher than 1,935 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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