Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn

Conditions
-----------------
Postprandial Heartburn

Intervention / Treatment
-----------------
* Device: IQP-LH-101 tablet
* Device: IQP-LH-101 liquid
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-prandial heartburn (e.g. after a high-fat meal) in at least 2 months prior to the study (at least 2 times a week) Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders Written informed consent is a prerequisite for subject enrollment. Exclusion Criteria: Gastrointestinal bleeding within 12 months prior to the study Difficulty swallowing (dysphagia) History of or symptoms suggestive of Zollinger-Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett's oesophagus or systemic sclerosis Participation in other studies within the last 30 days prior to entry or during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IQP-LH-101 tablet<br>4 chewable tablets to be chewed thoroughly before swallowing | Device: IQP-LH-101 tablet<br>* Oral medical device in the form of a chewable tablet<br>|
| Active Comparator: IQP-LH-101 liquid<br>2 liquid sachets to be emptied into the mouth and consumed. | Device: IQP-LH-101 liquid<br>* Oral medical device in the form of a liquid<br>|
| Placebo Comparator: Placebo<br>1 tablet to be swallowed with water. | Other: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms | The subject will be provided with a stopwatch started by the study staff at the time of investigational product application | Measured up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product | The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms. | Up to 4 hours | 
| Evaluation of efficacy | The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with very good, good, moderate and poor). | Up to 4 hours per crossover | 
| Adverse events | The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies. | Up to 4 weeks |