CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Octreotide +1 moredrug
Likely dose
Octreotide 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00426153
NCT00426153Phase 3Completed

Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease

Mayo Clinic·interventional·Posted Jan 24, 2007·Updated Nov 21, 2012

In Brief

A Phase 3 clinical trial evaluating Octreotide and Placebo for Polycystic Kidney, Autosomal Dominant and 5 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence indicates that this drug is safe and non-toxic in other disease states. Treatment with this drug holds promise not only for individuals with liver involvement, but also for many more patients with polycystic kidney disease.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2007
Enrollment StartJan 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.4 years ago

Interventions

Octreotidedrug

Participants received Octreotide LAR® Depot injections (up to 40 mg)intramuscularly every 28 days (+/- 5 days) for one year

Placebodrug

Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year