CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
Octreotidedrug
Likely dose
Octreotide starting 50 µg subcutaneously twice daily, escalating to 100 µg twice daily after 2 weeks, 200 µg twice daily after 4 weeks, and up to 400 µg twice daily if no response after 2 monthsAI-extracted
Key inclusion· 7
  • Enrolled in the lymphangioleiomyomatosis natural history protocol
  • Symptoms attributed to lymphangioleiomyomas
  • Symptoms attributed to chylous pleural effusions
  • Symptoms attributed to peripheral lymphedema
Key exclusion· 9
  • Hypersensitivity to somatostatin, octreotide, or octreotide analogues
  • Hepatitis B, hepatitis C, or other clinically significant liver disease
  • Transplant recipient status
  • Pregnancy or breastfeeding

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

Search/NCT00005906
NCT00005906Phase 2Completed

Treatment With Octreotide in Patients With Lymphangioleiomyomatosis

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Jun 12, 2000·Updated Apr 30, 2010

In Brief

A Phase 2 clinical trial evaluating Octreotide for Lymphangioleiomyomatosis and 3 related conditions. Completed, enrolled 4 participants across 1 site.

Detailed Summary

Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas). Within the LAM patient population is a subset of patients who develop chylous effusions and lymphangioleiomyomas. Treatment of many of these symptoms has been ineffective. Previous studies with somatostatin and octreotide in other clinical settings have shown reduction in chylous effusions. This study assesses the effectiveness of octreotide in symptomatic patients with LAM, lymphangioleiomyomas and/or chylous effusions/ascites, peripheral lymphedema and chyluria.

Study Details

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

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2000
Enrollment StartJun 1, 2000
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 26.1 years ago

Interventions

Octreotidedrug

Treatment with octreotide starts at a dose of 50 micrograms(ug) twice a day which is increased to 100 ug twice a day after two weeks and to 200 ug twice a day two weeks later. After two months, if there is no response the dose shall be increased to 400 ug twice a day.