Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly

PHASE4CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Acromegaly
Interventions
DRUG

Lanreotide-Autogel 120 mg

ATG120 mg is given as deep subcutaneous injection into the buttock. Each patient receives one deep subcutaneous injection of ATG120 mg at Visit 1 (V1) and subsequent injection every 4 weeks for 3 injections. Based on GH levels, the dosing interval has been determined as follows: if GH levels were \> 2.5 mcg/l, ATG 120 mg is given every 4 weeks while if they were \< 2.5 mcg/l ATG 120 mg is administered every 6 weeks for another 3 injections. Afterwards, the dose is maintained as above except in patients with GH levels \<1 mcg/l receiving ATG 120 mg every 8 weeks. The estimated duration of treatment is 48-52 weeks according with dose titration.

Trial Locations (1)

80131

Annamaria Colao, Naples

All Listed Sponsors
collaborator

University of Genova

OTHER

lead

Federico II University

OTHER

NCT00627796 - Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly | Biotech Hunter | Biotech Hunter