CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Lanreotidedrug
Likely dose
Lanreotide 120 mg subcutaneous injection, 3 injections over 12 weeks (one dose every 4 weeks)AI-extracted
Key inclusion· 4
  • Consecutive patients with evidence of small bowel motility disorders referred to or established patients at the Gastroenterology and Motility Center at Northwell Health System
  • Age 18 to 70 years
  • Small bowel motility disorder confirmed by wireless motility capsule (WMC) testing showing delayed transit >6 hours
  • Capable of understanding the study and providing informed consent
Key exclusion· 21
  • Age <18 or >70 years
  • Pregnancy (confirmed by urine pregnancy test)
  • History of gastric bezoar
  • Disorders of swallowing or severe dysphagia to food or pills

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03012594
NCT03012594Phase 2Completed

A Pilot Study to Evaluate Safety and Effectiveness of Lanreotide in the Treatment of Patients With Small Bowel Motility Disorders (SBMD): a Prospective, Non-randomized, Single-center Study of 20 Participants

Northwell Health·interventional·Posted Jan 6, 2017·Updated Jan 15, 2021

In Brief

A Phase 2 clinical trial evaluating Lanreotide for Gastrointestinal Motility Disorder and Intestinal Disease. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsIpsen

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 6, 2017
Enrollment StartMay 11, 2017
Primary CompletionOct 21, 2018
Study CompletionMar 11, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.5 years ago

Interventions

Lanreotidedrug

Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart