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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQP-LH-101 tablet | Active Comparator | 4 chewable tablets to be chewed thoroughly before swallowing |
|
| IQP-LH-101 liquid | Active Comparator | 2 liquid sachets to be emptied into the mouth and consumed. |
|
| Placebo | Placebo Comparator | 1 tablet to be swallowed with water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQP-LH-101 tablet | Device | Oral medical device in the form of a chewable tablet |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weißenseerweg 111 | Berlin | State of Berlin | 10369 | Germany |
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| IQP-LH-101 liquid |
| Device |
Oral medical device in the form of a liquid |
|
| Placebo | Other |
|
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 |