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NCT01037452 · ClinicalTrials.gov registry record · Phase 2
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT01037452: Completed Phase 2 study, sponsored by Novartis.
NCT01037452 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01037452, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.
Primary Outcome
Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.
Interventions
- DRUG Placebo
- DRUG Lansoprazole
- DRUG Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg
- DRUG Calcium carbonate/magnesium hydroxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2009-12 |
| Phase | Phase 2 |
What the finished NCT01037452 record still lists
NCT01037452 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01037452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01037452 about?
NCT01037452 is a clinical study titled "Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn". This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.
What is the current status of trial NCT01037452?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2009-12.
What interventions are being tested in trial NCT01037452?
The interventions under investigation include: Placebo (DRUG), Lansoprazole (DRUG), Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg (DRUG), Calcium carbonate/magnesium hydroxide (DRUG).
Who is sponsoring clinical trial NCT01037452?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01037452's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 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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