NCT03012594

Lanreotide in the Treatment of Small Bowel Motility Disorders

Completed Phase 2 Results posted Last updated 15 January 2021

What this trial tests

Phase 2 trial testing Lanreotide in Gastrointestinal Motility Disorder in 12 participants. Completed in 11 March 2019.

Timeline

11 May 2017

Primary endpoint
21 October 2018

11 March 2019

Quick facts

Lead sponsor	Northwell Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	11 May 2017
Primary completion	21 October 2018
Estimated completion	11 March 2019
Sites	2 locations across United States

Drugs / interventions tested

• Lanreotide (LANREOTIDE) — full drug profile →

Conditions studied

• Gastrointestinal Motility Disorder — all drugs for Gastrointestinal Motility Disorder →
• Intestinal Disease — all drugs for Intestinal Disease →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 70, any sex, with Gastrointestinal Motility Disorder or Intestinal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill Primary · 3 months

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.

Gastric emptying time

Group	Value	95% CI
Lanreotide	371.52	± 45.18

Small bowel transit time

Group	Value	95% CI
Lanreotide	392	± 47.51

Colonic transit time

Group	Value	95% CI
Lanreotide	4767	± 1286

Small bowel and Colonic transit time

Group	Value	95% CI
Lanreotide	5159	± 1284

Whole gut transit time

Group	Value	95% CI
Lanreotide	5530	± 1322

Improvement in Symptoms as Accessed by "Patient Assessment of Upper GastroIntestinal Symptom Severity Index" Secondary · 3 months

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-

Heartburn/regurgitation

Group	Value	95% CI
Lanreotide	1.48	± 0.27

Nausea/vomiting

Group	Value	95% CI
Lanreotide	1.00	± 0.35

Fullness/early satiety

Group	Value	95% CI
Lanreotide	2.36	± 0.4

Bloating

Group	Value	95% CI
Lanreotide	2.43	± 0.47

Upper abdominal pain

Group	Value	95% CI
Lanreotide	2.14	± 0.62

Lower abdominal pain

Group	Value	95% CI
Lanreotide	2.00	± 0.51

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month after last dose, up to 4 months from the start for each subject.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lanreotide

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (2 terms — click to expand)

Reaction	System	Lanreotide
Difficulty swallowing wireless motility capsule pill	Investigations	—
Unable to acknowledge the passage of the wireless motility capsule through the feces	Investigations	—

Data from ClinicalTrials.gov NCT03012594 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.