The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

March 31, 2014

Study Completion Date

May 31, 2016

Conditions
Acromegaly
Interventions
DRUG

saline

Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.

DRUG

DG3173

Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.

DRUG

octreotide

Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.

All Listed Sponsors
lead

Aspireo Pharmaceuticals Limited

INDUSTRY