NCT02217800

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

The Effect of Subcutaneous Infusions of 3 Doses of a Novel Somatostatin Analogue, DG3173, on Growth Hormone Levels in Untreated Acromegalics

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Aspireo Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the effect of the different continuous s.c. infusion treatments on the human growth hormone (hGH) levels in untreated acromegalic patients in comparison to a standard dose of octreotide. In addition, the pharmacokinetic profile and the safety and tolerability of DG3173 after continuous s.c. infusion will be evaluated.

Conditions

• Acromegaly

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-03-01
• Completion: 2016-05-01
• First posted: 2014-08-15
• Last updated: 2018-02-15
• Results posted: 2018-02-15