Lanreotide in the Treatment of Small Bowel Motility Disorders
NCT ID: NCT03012594
Last Updated: 2021-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2017-05-11
2019-03-11
Brief Summary
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Detailed Description
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If a patient is interested and qualifies for the study then he/she will be explained about the study and signature will be collected on the consent form. Health and social history will be collected. Blood work, urine analysis, pregnancy test (in women of reproductive age group and have the capability of getting pregnant)) will be performed to make sure that patient qualifies for the study and for follow-up during the treatment. Physical examination, ECG, wireless motility capsule testing and hydrogen breath testing will be performed. Patients will be required to complete a questionnaire regarding their health.
The total study duration from the first administration of study drug is 12 weeks. The study medication will be given once a month for 3 months and there is a 1 month follow-up after the last study medication. There will be a screening visit approximately 1 month before the first study drug administration.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lanreotide
Open label
Lanreotide
Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
Interventions
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Lanreotide
Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged between 18 and 70 years.
3. Subjects should be capable of understanding the study and be able to give informed consent.
4. Patient having small bowel motility disorder as evidenced by delayed small bowel transit by wireless motility capsule (WMC) testing to \> 6 hours.
5. To participate in the study, patients will have to stop taking Octreotide (because it has the same mechanism of action as the study medication) if they are currently taking it; it should be stopped for at least 4 weeks before taking the first dose of this study medication.
Exclusion Criteria
2. Pregnancy as assessed by urine pregnancy test.
1. History of gastric bezoar
2. History of Disorders of swallowing
3. Known or suspected small bowel diverticula, diverticulitis, strictures, fistulas, Crohn's disease, or any other relevant medical comorbidity (e.g. chronic alcohol abuse)
4. Prior intestinal surgery, including Ileocecal(IC) valve resection or gastrointestinal surgeries that create a blind loop (e.g. Bilroth II or Roux-en-Y)
5. History of Severe dysphagia to food or pills
6. A participant who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
7. Inability to be off intestinal transit altering medication for at least one week (e.g. opiates, laxatives, etc.)
8. Any person unable or unwilling to undergo abdominal surgery.
9. BMI \> 40.
1. Current use or recent (within last 7 days) use of acid suppressive therapy, prokinetic agents, laxatives, and opiates, or other agents known to affect gastrointestinal motility.
2. Disorders associated with presumed small intestinal motility disorders including: scleroderma, intestinal pseudo-obstruction, and autonomic visceral neuropathy (e.g. longstanding diabetes of more than 20 years and/or poorly controlled diabetes (glucose \> 250, glycosylated hemoglobin (HbA1c) \> 8.5%)
3. Current use of cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower heart rate, such as beta blockers.
4. Cardiac arrhythmia based on health history (palpitations, feeling a pause between heartbeats, lightheadedness, passing out, shortness of breath, or chest pain).
Bradycardia and Tachycardia are monitored during every visit to the clinic, using pulse rate.
ECG will be performed during screening visit and during 8th week of the study. The following are accessed with ECG.
* Bradycardia \<60 beats/min.
* Tachycardia \>100 beats/min.
* Atrial Fibrillation - Rapid irregular atrial signal with no real P-waves and irregular ventricular rate.
* Ventricular Fibrillation - Irregular ventricular waveforms.
* Sinus Arrhythmia - Normal beats, but triggered at an irregular interval from 60 to 100 beats per minute, causing varying R-R interval.
* Missed beats.
5. Chronic kidney disease (moderate and severe renal impairment as calculated by creatinine clearance of \<50 mL/min)
6. Hepatic Impairment - Subjects with Child-Pugh Class B and Class C.
7. Significant electrolyte abnormalities: Anything outside of the normal range by +/- 20 % will be considered as abnormal.
8. Cholelithiasis (Total bilirubin \>2x of normal)
9. Pancreatitis
10. Hepatitis (Aspartate transaminase (AST), Alanine transaminase (ALT) or Alkaline phosphatase (Alk Ph), greater than upper limit of normal(ULN), Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range)
11. Present cholecystitis
12. Uncontrolled congestive heart failure
13. Known hypersensitivity to the study drug
18 Years
70 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Northwell Health
OTHER
Responsible Party
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Larry Miller
Chief of Gastroenterology
Principal Investigators
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Larry Miller, M.D.
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Long Island Jewish Medical Center
New Hyde Park, New York, United States
Lenox Hill Hospital
New York, New York, United States
Countries
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References
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Soudah HC, Hasler WL, Owyang C. Effect of octreotide on intestinal motility and bacterial overgrowth in scleroderma. N Engl J Med. 1991 Nov 21;325(21):1461-7. doi: 10.1056/NEJM199111213252102.
Owyang C. Octreotide in gastrointestinal motility disorders. Gut. 1994;35(3 Suppl):S11-4. doi: 10.1136/gut.35.3_suppl.s11.
Edmunds MC, Chen JD, Soykan I, Lin Z, McCallum RW. Effect of octreotide on gastric and small bowel motility in patients with gastroparesis. Aliment Pharmacol Ther. 1998 Feb;12(2):167-74. doi: 10.1046/j.1365-2036.1998.00289.x.
Faure C, Goulet O, Ategbo S, Breton A, Tounian P, Ginies JL, Roquelaure B, Despres C, Scaillon M, Maurage C, Paquot I, Hermier M, De Napoli S, Dabadie A, Huet F, Baudon JJ, Larchet M. Chronic intestinal pseudoobstruction syndrome: clinical analysis, outcome, and prognosis in 105 children. French-Speaking Group of Pediatric Gastroenterology. Dig Dis Sci. 1999 May;44(5):953-9. doi: 10.1023/a:1026656513463.
Stanghellini V, Cogliandro RF, de Giorgio R, Barbara G, Salvioli B, Corinaldesi R. Chronic intestinal pseudo-obstruction: manifestations, natural history and management. Neurogastroenterol Motil. 2007 Jun;19(6):440-52. doi: 10.1111/j.1365-2982.2007.00902.x.
Mann SD, Debinski HS, Kamm MA. Clinical characteristics of chronic idiopathic intestinal pseudo-obstruction in adults. Gut. 1997 Nov;41(5):675-81. doi: 10.1136/gut.41.5.675.
Lybaert W. The use of lanreotide autogel(R) in the treatment of intestinal obstruction in a patient with adenocarcinoma. Case Rep Oncol. 2014 Jan 16;7(1):43-6. doi: 10.1159/000358124. eCollection 2014 Jan.
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.
Camilleri M. Small bowel motility disorders. Rev Gastroenterol Mex. 1994 Apr-Jun;59(2):120-6.
Wang C, Xu H, Chen H, Li J, Zhang B, Tang C, Ghishan FK. Somatostatin stimulates intestinal NHE8 expression via p38 MAPK pathway. Am J Physiol Cell Physiol. 2011 Feb;300(2):C375-82. doi: 10.1152/ajpcell.00421.2010. Epub 2010 Nov 24.
Giustina A, Chanson P, Bronstein MD, Klibanski A, Lamberts S, Casanueva FF, Trainer P, Ghigo E, Ho K, Melmed S; Acromegaly Consensus Group. A consensus on criteria for cure of acromegaly. J Clin Endocrinol Metab. 2010 Jul;95(7):3141-8. doi: 10.1210/jc.2009-2670. Epub 2010 Apr 21.
Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.
Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.
Rentz AM, Kahrilas P, Stanghellini V, Tack J, Talley NJ, de la Loge C, Trudeau E, Dubois D, Revicki DA. Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders. Qual Life Res. 2004 Dec;13(10):1737-49. doi: 10.1007/s11136-004-9567-x.
De Giorgio R, Sarnelli G, Corinaldesi R, Stanghellini V. Advances in our understanding of the pathology of chronic intestinal pseudo-obstruction. Gut. 2004 Nov;53(11):1549-52. doi: 10.1136/gut.2004.043968.
Iida H, Ohkubo H, Inamori M, Nakajima A, Sato H. Epidemiology and clinical experience of chronic intestinal pseudo-obstruction in Japan: a nationwide epidemiologic survey. J Epidemiol. 2013;23(4):288-94. doi: 10.2188/jea.je20120173.
Goulet O, Sauvat F, Jan D. Surgery for pediatric patients with chronic intestinal pseudo-obstruction syndrome. J Pediatr Gastroenterol Nutr. 2005 Sep;41 Suppl 1:S66-8. doi: 10.1097/01.scs.0000180312.55417.8e. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HS16-0465
Identifier Type: -
Identifier Source: org_study_id
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