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NCT02601703 · ClinicalTrials.gov registry record · Phase 3
To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)
A Phase 3 study, sponsored by Glenmark Pharmaceuticals Ltd. India.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,110
- Enrollment target
NCT02601703: Completed Phase 3 study, sponsored by Glenmark Pharmaceuticals Ltd. India.
NCT02601703 is a Phase 3 study that has completed, run by Glenmark Pharmaceuticals Ltd. India. The registered enrollment target is 1,110 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601703, a Phase 3 study, has completed, sponsored by Glenmark Pharmaceuticals Ltd. India.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,110 participants
- Enrollment target
Study Summary
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
Interventions
- DRUG Tacrolimus Ointment 0.1%
- DRUG Protopic® ointment, 0.1%
- DRUG Placebo of Tacrolimus Ointment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,110 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT02601703 record still lists
NCT02601703 is an interventional study that assigns participants to a tested intervention. Its 1,110 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 3 interventions - of which Tacrolimus Ointment 0.1% is the first listed.
NCT02601703 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02601703 about?
NCT02601703 is a clinical study titled "To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)". This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the T...
What is the current status of trial NCT02601703?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,110 participants. The study started on 2015-08. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02601703?
The interventions under investigation include: Tacrolimus Ointment 0.1% (DRUG), Protopic® ointment, 0.1% (DRUG), Placebo of Tacrolimus Ointment (DRUG).
Who is sponsoring clinical trial NCT02601703?
This trial is sponsored by Glenmark Pharmaceuticals Ltd. India, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02601703's enrollment target sits among peer trials
1,110 251st of 2000 higher than 1,750 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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