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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01718639
First received: October 25, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Postprandial Heartburn
 Device: IQP-LH-101 tablet
Device: IQP-LH-101 liquid
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

MedlinePlus related topics: Heartburn
U.S. FDA Resources

Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The subject will be provided with a stopwatch started by the study staff at the time of investigational product application


Secondary Outcome Measures:
  • Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product [ Time Frame: Up to 4 hours ] [ Designated as safety issue: No ]
    The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.

  • Evaluation of efficacy [ Time Frame: Up to 4 hours per crossover ] [ Designated as safety issue: No ]
    The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with "very good", "good", "moderate" and "poor").

  • Adverse events [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.


Enrollment: 41
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718639

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

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01718639     History of Changes
Other Study ID Numbers: INQ/012512
Study First Received: October 25, 2012
Last Updated: March 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 23, 2013