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NCT01371643 · ClinicalTrials.gov registry record · Phase 4

Surgical Debulking of Pituitary Adenomas

A Phase 4 study of Pituitary Adenoma, sponsored by NYU Langone Health.

Completed
Registry status
Phase 4
Development phase
41
Enrollment target
1
Study location

NCT01371643 is a Phase 4 study of Pituitary Adenoma that has completed, run by NYU Langone Health. The registered enrollment target is 41 participants, below the 284-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01371643, a Phase 4 study of Pituitary Adenoma, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 4
Development phase
41 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Octreotide LAR
  • PROCEDURE transsphenoidal surgery

Study Locations (1)

New York

  • New York University School of Medicine - New York

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2004-04
Est. Completion 2011-12
Phase Phase 4

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT01371643

The ClinicalTrials.gov registry entry for NCT01371643 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 9 other Pituitary Adenoma trials with a reported enrollment target (86% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pituitary Adenoma appearing as the primary indexed condition, and to 2 interventions - of which Octreotide LAR is the first listed.

NCT01371643 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01371643 about?

NCT01371643 is a clinical study titled "Surgical Debulking of Pituitary Adenomas". 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 ...

What is the current status of trial NCT01371643?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2004-04. Estimated completion is 2011-12.

What conditions does trial NCT01371643 study?

This clinical trial studies the following conditions: Pituitary Adenoma.

What interventions are being tested in trial NCT01371643?

The interventions under investigation include: Octreotide LAR (DRUG), transsphenoidal surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01371643?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01371643 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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