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NCT01674530 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation
A Phase 3 study, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 909
- Enrollment target
NCT01674530 is a Phase 3 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 909 participants.
The verdict
NCT01674530, a Phase 3 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 909 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation
Interventions
- DRUG Placebo
- DRUG Lubiprostone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 909 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01674530
The ClinicalTrials.gov registry entry for NCT01674530 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 909 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01674530 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01674530 about?
NCT01674530 is a clinical study titled "Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation". The objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients...
What is the current status of trial NCT01674530?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 909 participants. The study started on 2012-10. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01674530?
The interventions under investigation include: Placebo (DRUG), Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT01674530?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
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