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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Lanreotide in the Treatment of Small Bowel Motility Disorders

Overview

Status
Completed
Phase
Phase 2
Enrollment
12 participants (actual)
Sponsor
Northwell Health · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
11 May 2017
Primary completion
21 Oct 2018
Completion
11 Mar 2019
First posted
6 Jan 2017 (estimated)
Last update posted
15 Jan 2021
Conditions
Gastrointestinal Motility Disorder · Intestinal Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 2

    Lanreotide in the Treatment of Small Bowel Motility Disorders

    NCT03012594

    11 May 2017 to 11 Mar 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a human research study looking at the effectiveness of Lanreotide (study medication) in treating small bowel motility disorders. It is similar to a natural hormone somatostatin that is produced in the body in the stomach, duodenum, pancreas and brain. Somatostatin is a growth hormone-inhibiting hormone. Lanreotide is a man made hormone and is a long acting medication that is given once a month. It is marketed with a trade name "Somatuline Depot". It is given deep subcutaneously (deep within the layers of the skin) in the superior external quadrant of the buttock. Injection site will be alternated on subsequent injections.

Interventions

  • LanreotideDrug

Arms1

  • Experimental

    Lanreotide

    Open label

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill

    Time frame · 3 months

    Registry description

    If the small bowel transit time, as measured by wireless capsule endoscopy, is decreased to \< 6hrs, then patient would be considered a responder and that lanreotide is efficacious.

Secondary outcomes(1)
  1. Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"

    Time frame · 3 months

    Registry description

    Improvement in symptoms assessed by improvement in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index(PAGI-SYM) scores. If the PAGI-Sym scores were decreased by at least 0.7 points at 3 months when compared to baseline/pre treatment, then it will be considered that Lanreotide has significantly improved the symptom severity. Higher values represent worse symptoms. The participant rated each of the measured gastrointestinal symptom severity as described 0=No symptom, 1=Very Mild Symptom, 2= Mild Symptoms, 3= Moderate symptom, 4=Severe symptom, 5= Very Severe symptom. PAGI-SYM is a brief (20-items with 6 sub scales) symptom severity questionnaire that captures information on common upper gastrointestinal symptoms which include including Heartburn/regurgitation, Nausea/vomiting, Fullness/early satiety, bloating, Upper abdominal pain, and Lower abdominal pain. The presented data is an average of each sub scale.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill

GroupValue (minutes)Spread
Lanreotide371.5245.18
Secondary and other outcome results(1)
Secondary outcomeMean· 3 months

Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index"

GroupValue (score on a scale)Spread
Lanreotide1.480.27

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LanreotideOpen label Lanreotide: Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart0 / 90 / 92 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 1997

7 results

Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans.

Lamrani et al. 1997British journal of clinical pharmacologycited by 12

PMID 9056054DOI 10.1111/j.1365-2125.1997.tb00034.xPUB-09056054

Full text at the publisher7 results

More studies

3 studies on this page

Indexing hint: Case report · 2014

The use of lanreotide autogel® in the treatment of intestinal obstruction in a patient with adenocarcinoma.

Lybaert et al. 2014Case reports in oncologycited by 1

PMID 24575015PMC3934784DOI 10.1159/000358124PUB-24575015

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 1998

Effect of octreotide on gastric and small bowel motility in patients with gastroparesis.

Edmunds et al. 1998Alimentary pharmacology & therapeuticscited by 30

PMID 9692691DOI 10.1046/j.1365-2036.1998.00289.xPUB-09692691

Full text at the publisher
Publisher page

PubMed tag: none · 1991

Effect of octreotide on intestinal motility and bacterial overgrowth in scleroderma.

Soudah et al. 1991The New England journal of medicinecited by 262

PMID 1944424DOI 10.1056/nejm199111213252102PUB-01944424

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Consecutive patients with evidence of small bowel motility disorders, referred to (or) are patients of the Gastroenterology and Motility Center at Northwell Health System. 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. General Exclusion Criteria 1. Age \<18 or age \>70 2. Pregnancy as assessed by urine pregnancy test. Exclusion Criteria for performing wireless motility capsule testing 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. Exclusion Criteria due to Lanreotide 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

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