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

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Heartburn
• Intervention / Treatment: Other: Placebo; Device: IQP-LH-101 tablet; Device: IQP-LH-101 liquid

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Weißenseerweg 111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Placebo

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

Collaborators and Investigators

• Sponsor: InQpharm Group

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 28, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): March 11, 2013
• Last Update Submitted That Met QC Criteria: March 7, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn
• Other Study ID Numbers: INQ/012512

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No