CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
octreotide +1 moredrug
Likely dose
octreotide 300 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02235987
NCT02235987Phase 2Completed

A Study of the Effect of Ascending Single Doses of DG3173 and 300 μg of Octreotide on Human Growth Hormone Levels in Untreated Acromegalics.

Aspireo Pharmaceuticals Limited·interventional·Posted Sep 10, 2014·Updated Feb 15, 2018

In Brief

A Phase 2 clinical trial evaluating octreotide and DG3173 for Acromegaly. Completed, enrolled 20 participants.

Detailed Summary

The study is designed to investigate the safety, tolerability and efficacy of DG3173 in untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and one dose of octreotide, the current gold standard of medical therapy for acromegaly, with each patient receiving all doses of DG3173 as well as octreotide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2014
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2012
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.8 years ago

Interventions

octreotidedrug

Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.

DG3173drug

Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.