NCT02054637|UnknownPhase 2DMC
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Sponsor study identifier
interventional
10
1 country
1
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 29, 2014
Actual (reported)February 4, 2014
Actual (reported)April 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Los Angeles criteria for reflux esophagitis
Endoscopy at the start of the study will be compared with endoscopy at the end of the study.
4 weeks after the last injection with lanreotide
Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital of Brussels
Jette, 1090, Belgium
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.
Montesani 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.
Kim Moubax, Assistent
University hospital of Brussels, Laarbeeklaan, Jette
First Submitted
January 29, 2014
First Posted
February 4, 2014
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)
Contact the study team to confirm eligibility.
Gerard 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.
Swartz 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.
Gans 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.
Drewe 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.
Lamrani 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.
Ludlam 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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 4, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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