Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
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|ClinicalTrials.gov Identifier: NCT01718639|
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : March 11, 2013
This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in postprandial heartburn.
The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in terms of efficacy for postprandial heartburn treatment.
|Condition or disease||Intervention/treatment||Phase|
|Postprandial Heartburn||Device: IQP-LH-101 tablet Device: IQP-LH-101 liquid Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Active Comparator: IQP-LH-101 tablet
4 chewable tablets to be chewed thoroughly before swallowing
Device: IQP-LH-101 tablet
Oral medical device in the form of a chewable tablet
Active Comparator: IQP-LH-101 liquid
2 liquid sachets to be emptied into the mouth and consumed.
Device: IQP-LH-101 liquid
Oral medical device in the form of a liquid
Placebo Comparator: Placebo
1 tablet to be swallowed with water.
- Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms [ Time Frame: Measured up to 30 minutes ]The subject will be provided with a stopwatch started by the study staff at the time of investigational product application
- Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product [ Time Frame: Up to 4 hours ]The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.
- Evaluation of efficacy [ Time Frame: Up to 4 hours per crossover ]The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with "very good", "good", "moderate" and "poor").
- Adverse events [ Time Frame: Up to 4 weeks ]The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718639
|Berlin, Germany, 10369|