Trial intelligence / Profile preview

Preoperative Lanreotide in Acromegaly Macroadenomas

NCT00993356Phase 2

Key facts

Status: Unknown
Start: Jan 2004
Primary completion: Dec 2009
Countries: 1
Sponsor: Shanghai Jiao Tong University School of Medicine
Modality: Peptides

Drugs: lanreotide
Conditions: acromegaly

Overview

Phase 2, randomised, open-label trial of lanreotide in acromegaly (2 arms), sponsored by Shanghai Jiao Tong University School of Medicine. Primary endpoint: Surgical cure rate. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Preoperative Lanreotide
Lanreotide treatment for 4 months prior to surgery
Direct Surgery
Transsphenoidal surgery without preoperative medical treatment

Who it enrols

Newly diagnosed, previously untreated patients with acromegaly due to GH-secreting macroadenomas (>1 cm).

Endpoints

Primary

Surgical cure rate4 months postoperatively

Secondary

Postoperative hospital stay durationPost-surgery
Incidence of surgical complicationsPost-surgery

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