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NCT01005251 · ClinicalTrials.gov registry record · Phase 2
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 661
- Enrollment target
NCT01005251: Completed Phase 2 study, sponsored by AstraZeneca.
NCT01005251 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 661 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (397% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01005251, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 661 participants
- Enrollment target
Study Summary
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
Primary Outcome
Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease)
Interventions
- DRUG Placebo
- DRUG lesogaberan (AZD3355)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 661 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 2 |
What the finished NCT01005251 record still lists
NCT01005251 is an interventional study that assigns participants to a tested intervention. The registered 661 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (397% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01005251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01005251 about?
NCT01005251 is a clinical study titled "Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI". This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to ex...
What is the current status of trial NCT01005251?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 661 participants. The study started on 2009-10. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01005251?
The interventions under investigation include: Placebo (DRUG), lesogaberan (AZD3355) (DRUG).
Who is sponsoring clinical trial NCT01005251?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01005251's enrollment target sits among peer trials
661 49th of 2000 higher than 1,952 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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