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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 is a Phase 3 study that has completed, run by Glenmark Pharmaceuticals Ltd. India. The registered enrollment target is 1,110 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02601703
The ClinicalTrials.gov registry entry for NCT02601703 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glenmark Pharmaceuticals Ltd. India, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tacrolimus Ointment 0.1% is the first listed.
NCT02601703 reports 0 study locations.
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.
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