Back to resultsSafety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Primary Purpose
Postprandial Heartburn
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
IQP-LH-101 tablet
IQP-LH-101 liquid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postprandial Heartburn
Eligibility 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
Sites / Locations
- Weißenseerweg 111
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
IQP-LH-101 tablet
IQP-LH-101 liquid
Placebo
Arm Description
4 chewable tablets to be chewed thoroughly before swallowing
2 liquid sachets to be emptied into the mouth and consumed.
1 tablet to be swallowed with water.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product
The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.
Evaluation of efficacy
The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with "very good", "good", "moderate" and "poor").
Adverse events
The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01718639
Brief Title
Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Official Title
Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IQP-LH-101 tablet
Arm Type
Active Comparator
Arm Description
4 chewable tablets to be chewed thoroughly before swallowing
Arm Title
IQP-LH-101 liquid
Arm Type
Active Comparator
Arm Description
2 liquid sachets to be emptied into the mouth and consumed.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 tablet to be swallowed with water.
Intervention Type
Device
Intervention Name(s)
IQP-LH-101 tablet
Intervention Description
Oral medical device in the form of a chewable tablet
Intervention Type
Device
Intervention Name(s)
IQP-LH-101 liquid
Intervention Description
Oral medical device in the form of a liquid
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Difference in time to both onset of soothing and onset of cooling after intake of investigational product between study arms
Description
The subject will be provided with a stopwatch started by the study staff at the time of investigational product application
Time Frame
Measured up to 30 minutes
Secondary Outcome Measure Information:
Title
Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product
Description
The subject will be instructed to stop the stopwatch provided at first perception of recurring heartburn symptoms.
Time Frame
Up to 4 hours
Title
Evaluation of efficacy
Description
The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with "very good", "good", "moderate" and "poor").
Time Frame
Up to 4 hours per crossover
Title
Adverse events
Description
The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Weißenseerweg 111
City
Berlin
ZIP/Postal Code
10369
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
We'll reach out to this number within 24 hrs