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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014