Postprandial HeartburnPhase 4NCT01718639
Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
A Phase 4 study testing IQP-LH-101 tablet and IQP-LH-101 liquid in people with Postprandial Heartburn, run by InQpharm Group at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Heartburn
- What is being tested?
- IQP-LH-101 tablet and IQP-LH-101 liquid
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
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.
- Conditions
- Postprandial Heartburn
- Being tested
- IQP-LH-101 tablet, IQP-LH-101 liquid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQP-LH-101 tabletDevice
Oral medical device in the form of a chewable tablet
IQP-LH-101 liquidDevice
Oral medical device in the form of a liquid
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| IQP-LH-101 tablet | Active comparator | 4 chewable tablets to be chewed thoroughly before swallowing Receives: Device: IQP-LH-101 tablet |
| IQP-LH-101 liquid | Active comparator | 2 liquid sachets to be emptied into the mouth and consumed. Receives: Device: IQP-LH-101 liquid |
| Placebo | Placebo comparator | 1 tablet to be swallowed with water. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured up to 30 minutes
Secondary outcomes (3)
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.
Measured: Up to 4 hours
Evaluation of efficacy
The subjects evaluate the efficacy of the device under investigation (global scaled eval-uation with "very good", "good", "moderate" and "poor").
Measured: Up to 4 hours per crossover
Adverse events
The investigator will assess and document in the CRF any adverse events, device effects and device deficiencies.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HeartburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- InQpharm Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718639
- Sponsor's protocol ID
- INQ/012512
- Status last verified
- Mar 2013
- First submitted
- 25 Oct 2012
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Single-blind, Three-way Crossover Clinical Investigation to Evaluate Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
- ClinicalTrials.gov ID
- NCT01718639
- Acronym / sponsor ID
- INQ/012512
- Conditions
- Postprandial Heartburn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- InQpharm GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IQP-LH-101 tablet | Active comparator | Device: IQP-LH-101 tablet4 chewable tablets to be chewed thoroughly before swallowing |
| IQP-LH-101 liquid | Active comparator | Device: IQP-LH-101 liquid2 liquid sachets to be emptied into the mouth and consumed. |
| Placebo | Placebo comparator | Other: Placebo1 tablet to be swallowed with water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IQP-LH-101 tabletOral medical device in the form of a chewable tablet | Device | IQP-LH-101 tablet |
| IQP-LH-101 liquidOral medical device in the form of a liquid | Device | IQP-LH-101 liquid |
| Placebo | Other | Placebo |
Primary outcome
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
The subject will be provided with a stopwatch started by the study staff at the time of investigational product application
3 secondary outcomes
Duration of time until the first perception of recurring heartburn symptoms after intake of investigational product
Time frame: Up to 4 hours
Evaluation of efficacy
Time frame: Up to 4 hours per crossover
Adverse events
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IQP-LH-101 tablet and IQP-LH-101 liquid in people with Postprandial Heartburn, run by InQpharm Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2013.