Acid Reflux EsophagitisPhase 2NCT02054637
Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
A Phase 2 study testing Lanreotide in people with Acid Reflux Esophagitis and Non-acid Reflux Esophagitis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing almost completely bile salts output from the gallbladder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acid Reflux Esophagitis, Non-acid Reflux Esophagitis
- What is being tested?
- Lanreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Apr 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg (before breakfast and dinner) and 300 mg of H2 blocker ranitidine (at bedtime).
- The Los Angeles classification (LA) will be used to evaluate endoscopic reflux. Any distal esophageal ulcer with negative biopsy is also diagnostic for reflux.
- Persistent reflux is defined as:
- No reflux complaints but continuing endoscopic lesions and positive impedancemetry.
- Reflux complaints with continuing endoscopic lesions and positive impedancemetry.
- Reflux complaints without endoscopic lesions but positive impedancemetry.
Who cannot join
- Pregnancy or inadequate anticonception, breast feeding.
- Negative impedancemetry.
- Diabetes.
- Placement of a gastric ring for weight loss.
Trial locations and contacts
1 site in 1 country.
Kim Moubax, Assistent contact
Daniël Urbain, Professor contact
Belgium1 site
University Hospital of Brussels
Jette, 1090
Kim Moubax, Assistent, 003224749346 ext. 0032476486103, kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be
Daniël Urbain, Professor, daniel.urbain@uzbrussel.be
About this study
Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing almost completely bile salts output from the gallbladder. Somatostatine is also known to decrease acid production with significant increase of intragastric pH. In this way, somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder emptying and decreasing acid secretion.
Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that cannot be controlled with classic therapy.
Read the detailed description
Patients presenting with persistent esophagitis on endoscopy while on proton pump inhibitors (PPI) treatment will receive a maximal therapy consisting of 2 x 40 mg of PPI before the meals (morning and evening) and a H2 blocker before bedtime (standard practice). They will be reevaluated endoscopically and clinically 2 months later (standard practice). If reflux persists, objectivized by impedancemetry (standard practice), they will be asked to participate in this study.
Lanreotide autogel 120 mg deep subcutaneously every 4 weeks will be added to the treatment. A total of 3 injections per patient have been foreseen in this proof of concept study.
Patients will be reevaluated clinically after 2, 4 and 8 weeks. At the end of the study a new upper gastrointestinal endoscopy and impedancemetry will be performed.
- Being tested
- Lanreotide
- Keywords
- Bile reflux, Reflux esophagitis, Lanreotide autogel, Somatuline, Endoscopy, Impedancemetry
- Medical subject headings
- Bile Reflux, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanreotideDrug
Also called Somatuline
| Study group | Role | What they receive |
|---|---|---|
| Lanreotide | Experimental | Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections) Receives: Drug: Lanreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Los Angeles criteria for reflux esophagitis
Endoscopy at the start of the study will be compared with endoscopy at the end of the study.
Measured: 4 weeks after the last injection with lanreotide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acid Reflux EsophagitisStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Moubax, Universitair Ziekenhuis Brussel
- Investigators
- Kim Moubax, Assistent, Study chair, University hospital of Brussels, Laarbeeklaan, Jette
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054637
- Sponsor's protocol ID
- PHV106-B.05
- Status last verified
- Jan 2014
- First submitted
- 29 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
PubMed 16240061Montesani C, D'Amato A, Santella S, Pronio A, Giovannini C, Cristaldi M, Ribotta G. Billroth I versus Billroth II versus Roux-en-Y after subtotal gastrectomy. Prospective [correction of prespective] randomized study. Hepatogastroenterology. 2002 Sep-Oct;49(47):1469-73.
PubMed 12239969Gerard PS, Gerczuk P, Finestone H. Bile reflux in the esophagus demonstrated by HIDA scintigraphy. Clin Nucl Med. 2007 Mar;32(3):224-5. doi: 10.1097/01.rlu.0000255039.24698.48. No abstract available.
PubMed 17314604Swartz DE, Mobley E, Felix EL. Bile reflux after Roux-en-Y gastric bypass: an unrecognized cause of postoperative pain. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):27-30. doi: 10.1016/j.soard.2008.10.009. Epub 2008 Oct 30.
PubMed 19095503Gans SL, van Westreenen HL, Kiewiet JJ, Rauws EA, Gouma DJ, Boermeester MA. Systematic review and meta-analysis of somatostatin analogues for the treatment of pancreatic fistula. Br J Surg. 2012 Jun;99(6):754-60. doi: 10.1002/bjs.8709. Epub 2012 Mar 20.
PubMed 22430616Drewe J, Sieber CC, Mottet C, Wullschleger C, Larsen F, Beglinger C. Dose-dependent gastrointestinal effects of the somatostatin analog lanreotide in healthy volunteers. Clin Pharmacol Ther. 1999 Apr;65(4):413-9. doi: 10.1016/S0009-9236(99)70136-0.
PubMed 10223779Lamrani A, Vidon N, Sogni P, Nepveux P, Catus F, Blumberg J, Chaussade S. Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans. Br J Clin Pharmacol. 1997 Jan;43(1):65-70. doi: 10.1111/j.1365-2125.1997.tb00034.x.
PubMed 9056054Ludlam WH, Anthony L. Safety review: dose optimization of somatostatin analogs in patients with acromegaly and neuroendocrine tumors. Adv Ther. 2011 Oct;28(10):825-41. doi: 10.1007/s12325-011-0062-9. Epub 2011 Sep 28.
PubMed 21964965
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
- ClinicalTrials.gov ID
- NCT02054637
- Acronym / sponsor ID
- PHV106-B.05
- Keywords
- Bile reflux, Reflux esophagitis, Lanreotide autogel, Somatuline, Endoscopy, Impedancemetry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 4 Feb 2014 (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.
Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing almost completely bile salts output from the gallbladder. Somatostatine is also known to decrease acid production with significant increase of intragastric pH. In this way, somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder emptying and decreasing acid secretion.
Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that cannot be controlled with classic therapy.
Detailed description
Patients presenting with persistent esophagitis on endoscopy while on proton pump inhibitors (PPI) treatment will receive a maximal therapy consisting of 2 x 40 mg of PPI before the meals (morning and evening) and a H2 blocker before bedtime (standard practice). They will be reevaluated endoscopically and clinically 2 months later (standard practice). If reflux persists, objectivized by impedancemetry (standard practice), they will be asked to participate in this study.
Lanreotide autogel 120 mg deep subcutaneously every 4 weeks will be added to the treatment. A total of 3 injections per patient have been foreseen in this proof of concept study.
Patients will be reevaluated clinically after 2, 4 and 8 weeks. At the end of the study a new upper gastrointestinal endoscopy and impedancemetry will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lanreotide | Experimental | Drug: LanreotideLanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg (before breakfast and dinner) and 300 mg of H2 blocker ranitidine (at bedtime).
- The Los Angeles classification (LA) will be used to evaluate endoscopic reflux. Any distal esophageal ulcer with negative biopsy is also diagnostic for reflux.
- No reflux complaints but continuing endoscopic lesions and positive impedancemetry.
- Reflux complaints with continuing endoscopic lesions and positive impedancemetry.
- Reflux complaints without endoscopic lesions but positive impedancemetry.
Key exclusion criteria (4 listed)
- Pregnancy or inadequate anticonception, breast feeding.
- Negative impedancemetry.
- Diabetes.
- Placement of a gastric ring for weight loss.
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 |
|---|---|---|
| LanreotideAlso: Somatuline | Drug | Lanreotide |
Primary outcome
Los Angeles criteria for reflux esophagitis
Time frame: 4 weeks after the last injection with lanreotide
Endoscopy at the start of the study will be compared with endoscopy at the end of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Background: PubMed 16240061Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
- Background: PubMed 12239969Montesani C, D'Amato A, Santella S, Pronio A, Giovannini C, Cristaldi M, Ribotta G. Billroth I versus Billroth II versus Roux-en-Y after subtotal gastrectomy. Prospective [correction of prespective] randomized study. Hepatogastroenterology. 2002 Sep-Oct;49(47):1469-73.
- Background: PubMed 17314604Gerard PS, Gerczuk P, Finestone H. Bile reflux in the esophagus demonstrated by HIDA scintigraphy. Clin Nucl Med. 2007 Mar;32(3):224-5. doi: 10.1097/01.rlu.0000255039.24698.48. No abstract available.
- Background: PubMed 19095503Swartz DE, Mobley E, Felix EL. Bile reflux after Roux-en-Y gastric bypass: an unrecognized cause of postoperative pain. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):27-30. doi: 10.1016/j.soard.2008.10.009. Epub 2008 Oct 30.
- Background: PubMed 22430616Gans SL, van Westreenen HL, Kiewiet JJ, Rauws EA, Gouma DJ, Boermeester MA. Systematic review and meta-analysis of somatostatin analogues for the treatment of pancreatic fistula. Br J Surg. 2012 Jun;99(6):754-60. doi: 10.1002/bjs.8709. Epub 2012 Mar 20.
- Background: PubMed 10223779Drewe J, Sieber CC, Mottet C, Wullschleger C, Larsen F, Beglinger C. Dose-dependent gastrointestinal effects of the somatostatin analog lanreotide in healthy volunteers. Clin Pharmacol Ther. 1999 Apr;65(4):413-9. doi: 10.1016/S0009-9236(99)70136-0.
- Background: PubMed 9056054Lamrani A, Vidon N, Sogni P, Nepveux P, Catus F, Blumberg J, Chaussade S. Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans. Br J Clin Pharmacol. 1997 Jan;43(1):65-70. doi: 10.1111/j.1365-2125.1997.tb00034.x.
- Background: PubMed 21964965Ludlam WH, Anthony L. Safety review: dose optimization of somatostatin analogs in patients with acromegaly and neuroendocrine tumors. Adv Ther. 2011 Oct;28(10):825-41. doi: 10.1007/s12325-011-0062-9. Epub 2011 Sep 28.
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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.
Kim Moubax, Assistent contact
Daniël Urbain, Professor contact
Kim Moubax, Assistent study chair
University hospital of Brussels, Laarbeeklaan, Jette
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lanreotide in people with Acid Reflux Esophagitis and Non-acid Reflux Esophagitis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 6 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: status not confirmed, as of the sponsor's last update on 4 Feb 2014. 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 Belgium. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Moubax, Assistent (003224749346 ext. 0032476486103, kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Los Angeles criteria for reflux esophagitis (time frame: 4 weeks after the last injection with lanreotide). 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 NCT02054637, which also lists 8 linked publications.
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 4 Feb 2014.