CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
Octreotide LAR +1 moredrug
Likely dose
Not stated in 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/NCT01371643
NCT01371643Phase 4Completed

Does Surgical Debulking Of Pituitary Adenomas Improve Responsiveness To Octreotide LAR In The Treatment Of Acromegaly: An Investigator-Initiated Study

NYU Langone Health·interventional·Posted Jun 13, 2011·Updated Aug 29, 2016

In Brief

A Phase 4 clinical trial evaluating Octreotide LAR and transsphenoidal surgery for Pituitary Adenoma. Completed, enrolled 41 participants across 1 site.

Detailed Summary

This is a randomized, multicenter trial with stratification done by a single radiologist at the coordinating center (NYU), and patients with comparable disease will be randomized to Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine whether surgery (debulking of pituitary adenomas) improves the response of patients with acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.

Study Details

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

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 13, 2011
Enrollment StartApr 1, 2004
Primary CompletionJul 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 15.1 years ago

Interventions

Octreotide LARdrug

transsphenoidal surgeryprocedure