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

InQpharm

Status and phase: Completed; Phase 4

Conditions: Postprandial Heartburn

Treatments: Device: IQP-LH-101 tablet; Other: Placebo; Device: IQP-LH-101 liquid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01718639

INQ/012512

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 3 patient groups, including a placebo group

IQP-LH-101 tablet

Active Comparator group

Description:

4 chewable tablets to be chewed thoroughly before swallowing

Treatment:

Device: IQP-LH-101 tablet

IQP-LH-101 liquid

Active Comparator group

Description:

2 liquid sachets to be emptied into the mouth and consumed.

Treatment:

Device: IQP-LH-101 liquid

Placebo

Placebo Comparator group

Description:

1 tablet to be swallowed with water.

Treatment:

Other: Placebo