Postprandial Heartburn Clinical Trial
Official title:
Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
| Verified date | March 2013 |
| Source | InQpharm Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Weißenseerweg 111 | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| InQpharm Group |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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. | Up to 4 hours | No |
| Secondary | Evaluation of efficacy | The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with "very good", "good", "moderate" and "poor"). | Up to 4 hours per crossover | No |
| Secondary | Adverse events | The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies. | Up to 4 weeks | Yes |