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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01718639

Enrollment

Registered

2012-10-31

Start date

2012-10-31

Completion date

2013-03-31

Last updated

2013-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial Heartburn

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.

Interventions

DEVICEIQP-LH-101 tablet

Oral medical device in the form of a chewable tablet

DEVICEIQP-LH-101 liquid

Oral medical device in the form of a liquid

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms	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

Secondary

Measure	Time frame	Description
Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product	Up to 4 hours	The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.
Evaluation of efficacy	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	Up to 4 weeks	The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026