Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
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.
|Postprandial Heartburn||Device: IQP-LH-101 tablet Device: IQP-LH-101 liquid Other: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn|
- 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.
|Study Start Date:||October 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718639
|Berlin, Germany, 10369|