Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
NCT ID: NCT01718639
Last Updated: 2013-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2012-10-31
2013-03-31
Brief Summary
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The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in terms of efficacy for postprandial heartburn treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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IQP-LH-101 tablet
4 chewable tablets to be chewed thoroughly before swallowing
IQP-LH-101 tablet
Oral medical device in the form of a chewable tablet
IQP-LH-101 liquid
2 liquid sachets to be emptied into the mouth and consumed.
IQP-LH-101 liquid
Oral medical device in the form of a liquid
Placebo
1 tablet to be swallowed with water.
Placebo
Interventions
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IQP-LH-101 tablet
Oral medical device in the form of a chewable tablet
IQP-LH-101 liquid
Oral medical device in the form of a liquid
Placebo
Eligibility Criteria
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Inclusion Criteria
* Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders
* Written informed consent is a prerequisite for subject enrollment.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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InQpharm Group
INDUSTRY
Responsible Party
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Locations
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Weißenseerweg 111
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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INQ/012512
Identifier Type: -
Identifier Source: org_study_id
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