Gastroesophageal Reflux DiseaseNCT01053585
Structure and Function of the Gastro-esophageal Junction
A study testing Baclofen in people with Gastroesophageal Reflux Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
Aims of research project: To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging. Hypothesis: 1. Functional factors including GEJ function (e.g. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2007to May 2011
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Study #1:
- healthy male and female volunteers
- aged at least 18 and not more than 49 y
- no history of gastrointestinal symptoms
- able to communicate well with the investigators and to comply with the requirements for the entire study
- who provided written informed consent before participating in the study, after being given a full description of the trail.
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- Study #2 and #3:
- male and female patients with mild to moderate gastro-oesophageal reflux disease defined by presence of (1) reflux symptoms (2) pathological esophageal acid exposure between 5-10% on 24 hour ambulatory testing
- aged at least 18 and not more than 49 y
- no history of gastrointestinal symptoms
- able to communicate well with the investigators and to comply with the requirements for the entire study
- who provided written informed consent before participating in the study, after being given a full description of the trail.
Who cannot join
- with present psychiatric disorders or mental impairment limiting the ability to comply with study requirements
- with use of medications influencing upper GI motility within one week of the study (i.e. beta- blocker, calcium channel blockers, nitrates, prokinetic drugs, macrolide antibiotics)
- with regular intake of medication; occasional use of analgesic e.g. aspirin, paracetamol is allowed
- with symptoms or a history of gastrointestinal disease other than gastro-esophageal reflux disease (in study #2 and #3)
- suffering from known liver, kidney, cardiovascular, neurological or pulmonary disease
- with any evidence of infectious disease
- with evidence or history of drug or alcohol abuse
- with insufficient knowledge of the German language • who, for any reason, are unable to complete the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Gastroenterology
Zurich, Canton of Zurich, CH-8091
About this study
Official title: Combined Magnetic Resonance Imaging and High Resolution Manometry Studies
Aims of research project:
To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging.
Read more
Hypothesis:
- Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however
- Structural factors including separation of GEJ anatomy, intra-gastric distribution of the meal and secretions determine whether TLESR is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').
- Initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Baclofen, Placebo
- Keywords
- Gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
PlaceboDrug
Placebo single 'dose' 90 minutes prior to study
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | Active comparator | Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement) Receives: Drug: Baclofen |
| Placebo | Placebo comparator | Placebo suspension (single dose 90 minutes prior to physiologic measurement) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)
Gastro-oesophageal morphology from MRI imaging: insertion angle, contact span (of stomach on oesophagus) assessed from 3D models of stomach reconstructed from MRI imaging
Measured: Pre- and post-meal ingestion
Secondary outcomes (3)
gastric emptying
dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric emptying assessed from complete data set
Measured: post-meal
gastric accommodation
dynamic change in gastric and meal volumes over course of study assessed from MRI imaging. gastric accommodation assessed from complete data set
Measured: post-meal
number of reflux events
assessed by presence of common cavity events on (high resolution) manometry
Measured: post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startFeb 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053585
- Sponsor's protocol ID
- EK 1361
- Status last verified
- May 2011
- First submitted
- 21 Jul 2009
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Curcic J, Roy S, Schwizer A, Kaufman E, Forras-Kaufman Z, Menne D, Hebbard GS, Treier R, Boesiger P, Steingoetter A, Fried M, Schwizer W, Pal A, Fox M. Abnormal structure and function of the esophagogastric junction and proximal stomach in gastroesophageal reflux disease. Am J Gastroenterol. 2014 May;109(5):658-67. doi: 10.1038/ajg.2014.25. Epub 2014 Mar 4.
PubMed 24589669
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Magnetic Resonance Imaging and High Resolution Manometry Studies
- ClinicalTrials.gov ID
- NCT01053585
- Acronym / sponsor ID
- EK 1361
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastro-esophageal junction, reflux, insertion angle, magnetic resonance imaging, manometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jan 2010 (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.
Aims of research project:
To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging.
Hypothesis:
- Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however
- Structural factors including separation of GEJ anatomy, intra-gastric distribution of the meal and secretions determine whether TLESR is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').
- Initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Active comparator | Drug: BaclofenBaclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo suspension (single dose 90 minutes prior to physiologic measurement) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- healthy male and female volunteers
- aged at least 18 and not more than 49 y
- no history of gastrointestinal symptoms
- able to communicate well with the investigators and to comply with the requirements for the entire study
- who provided written informed consent before participating in the study, after being given a full description of the trail.
Key exclusion criteria (8 listed)
- with present psychiatric disorders or mental impairment limiting the ability to comply with study requirements
- with use of medications influencing upper GI motility within one week of the study (i.e. beta- blocker, calcium channel blockers, nitrates, prokinetic drugs, macrolide antibiotics)
- with regular intake of medication; occasional use of analgesic e.g. aspirin, paracetamol is allowed
- with symptoms or a history of gastrointestinal disease other than gastro-esophageal reflux disease (in study #2 and #3)
- suffering from known liver, kidney, cardiovascular, neurological or pulmonary disease
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 |
|---|---|---|
| BaclofenBaclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement) | Drug | Baclofen |
| PlaceboPlacebo single 'dose' 90 minutes prior to study | Drug | Placebo |
Primary outcome
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)
Time frame: Pre- and post-meal ingestion
Gastro-oesophageal morphology from MRI imaging: insertion angle, contact span (of stomach on oesophagus) assessed from 3D models of stomach reconstructed from MRI imaging
3 secondary outcomes
gastric emptying
Time frame: post-meal
gastric accommodation
Time frame: post-meal
number of reflux events
Time frame: post-meal
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 2 Jun 2011.
- Derived from this study: PubMed 24589669Curcic J, Roy S, Schwizer A, Kaufman E, Forras-Kaufman Z, Menne D, Hebbard GS, Treier R, Boesiger P, Steingoetter A, Fried M, Schwizer W, Pal A, Fox M. Abnormal structure and function of the esophagogastric junction and proximal stomach in gastroesophageal reflux disease. Am J Gastroenterol. 2014 May;109(5):658-67. doi: 10.1038/ajg.2014.25. Epub 2014 Mar 4.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baclofen in people with Gastroesophageal Reflux Disease, run by University of Zurich at 1 site in Switzerland.
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 12 inclusion and 8 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 2 Jun 2011. 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 Switzerland. 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.
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?
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus) (time frame: Pre- and post-meal ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053585, which also lists 1 linked publication.
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 2 Jun 2011.