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

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ClinicalTrials.gov Identifier: NCT01718639
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : March 11, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Postprandial Heartburn Device: IQP-LH-101 tablet Device: IQP-LH-101 liquid Other: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Study Start Date : October 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718639

Weißenseerweg 111
Berlin, Germany, 10369
Sponsors and Collaborators
InQpharm Group
More Information

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01718639     History of Changes
Other Study ID Numbers: INQ/012512
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: March 11, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms