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NCT01814553 · ClinicalTrials.gov registry record · Phase 3
ADAM-Afatinib Diarrhea Assessment and Management
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT01814553 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 40 participants.
The verdict
NCT01814553, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the use of diarrheal management tools intended to facilitate timely intervention and treatment modifications due to afatinib treatment-related diarrhea in patients with EGFR mutations-positive adenocarcinoma of the lung. Patients in Cohort 1 will follow diarrhea management. Patients in Cohort 2 will receive prophylactic loperamide starting the fist day of afatinib treatment.
Interventions
- DRUG afatinib
- DRUG loperamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01814553
The ClinicalTrials.gov registry entry for NCT01814553 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which afatinib is the first listed.
NCT01814553 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01814553 about?
NCT01814553 is a clinical study titled "ADAM-Afatinib Diarrhea Assessment and Management". This is a non-randomized, open label, two-cohort, multi-institutional study to evaluate the use of diarrheal management tools intended to facilitate timely intervention and treatment modifications due to afatinib treatment-related diarrhea in patients with EGFR mutations-positive adenocarcinoma of t...
What is the current status of trial NCT01814553?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2013-04. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01814553?
The interventions under investigation include: afatinib (DRUG), loperamide (DRUG).
Who is sponsoring clinical trial NCT01814553?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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