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NCT00001860 · ClinicalTrials.gov registry record · Phase 2

Sandostatin LAR Depot vs. Surgery for Treating Acromegaly

A Phase 2 study of Acromegaly and Pituitary Neoplasm, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 2
Development phase
5
Enrollment target
1
Study location

NCT00001860 is a Phase 2 study of Acromegaly and Pituitary Neoplasm that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 5 participants, below the 101-participant average among 13 other Acromegaly trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001860, a Phase 2 study of Acromegaly and Pituitary Neoplasm, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 2
Development phase
5 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.

Interventions

  • DRUG Sandostatin LAR Depot versus transsphenoidal surgery

Study Locations (1)

Maryland

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - Bethesda

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 1999-08
Est. Completion 2002-07
Phase Phase 2

What the Registry Record Tells You About NCT00001860

The ClinicalTrials.gov registry entry for NCT00001860 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 101-participant average among 13 other Acromegaly trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acromegaly appearing as the primary indexed condition, and to 1 intervention - of which Sandostatin LAR Depot versus transsphenoidal surgery is the first listed.

NCT00001860 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001860 about?

NCT00001860 is a clinical study titled "Sandostatin LAR Depot vs. Surgery for Treating Acromegaly". The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compa...

What is the current status of trial NCT00001860?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 1999-08. Estimated completion is 2002-07.

What conditions does trial NCT00001860 study?

This clinical trial studies the following conditions: Acromegaly, Pituitary Neoplasm.

What interventions are being tested in trial NCT00001860?

The interventions under investigation include: Sandostatin LAR Depot versus transsphenoidal surgery (DRUG).

Who is sponsoring clinical trial NCT00001860?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001860 being conducted?

This trial has 1 study location across Maryland. 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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