Skip to main content
OpenTrials
Completed

NCT Number: NCT01718639

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postprandial Heartburn

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Weißenseerweg 111

Berlin, State of Berlin, 10369, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IQP-LH-101 tablet

Device

Oral medical device in the form of a chewable tablet

IQP-LH-101 liquid

Device

Oral medical device in the form of a liquid

Placebo

Other

Primary outcomes

  1. Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms

    Time frame: 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 outcomes

  1. Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product

    Time frame: Up to 4 hours

    The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.

  2. Evaluation of efficacy

    Time frame: 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").

  3. Adverse events

    Time frame: Up to 4 weeks

    The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 31, 2012
Registry last updated
Mar 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.