Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 11, 2013
March 1, 2013
5 months
October 25, 2012
March 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms
The subject will be provided with a stopwatch started by the study staff at the time of investigational product application
Measured up to 30 minutes
Secondary Outcomes (3)
Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product
Up to 4 hours
Evaluation of efficacy
Up to 4 hours per crossover
Adverse events
Up to 4 weeks
Study Arms (3)
IQP-LH-101 tablet
ACTIVE COMPARATOR4 chewable tablets to be chewed thoroughly before swallowing
IQP-LH-101 liquid
ACTIVE COMPARATOR2 liquid sachets to be emptied into the mouth and consumed.
Placebo
PLACEBO COMPARATOR1 tablet to be swallowed with water.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
Study Sites (1)
Weißenseerweg 111
Berlin, State of Berlin, 10369, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2012
First Posted
October 31, 2012
Study Start
October 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 11, 2013
Record last verified: 2013-03