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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: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01814553 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall incidence of patients who experienced diarrhea during the first three courses 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 |
What the finished NCT01814553 record still lists
NCT01814553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which afatinib is the first listed.
NCT01814553 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01814553's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 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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