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

Phase 4

Completed

• Conditions: Postprandial Heartburn
• Interventions: Device: IQP-LH-101 tablet; Device: IQP-LH-101 liquid; Other: Placebo

• Registration Number: NCT01718639
• Lead Sponsor: InQpharm Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-28
• Study First Posted: 2012-10-31
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IQP-LH-101 tablet	IQP-LH-101 tablet	4 chewable tablets to be chewed thoroughly before swallowing
IQP-LH-101 liquid	IQP-LH-101 liquid	2 liquid sachets to be emptied into the mouth and consumed.
Placebo	Placebo	1 tablet to be swallowed with water.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Adverse events	Up to 4 weeks	The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.
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").

Trial Locations

Locations (1)

Weißenseerweg 111; 🇩🇪 Berlin, Germany