Trial Outcomes & Findings for Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients. (NCT NCT02235987)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.

Results posted on

2018-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Octreotide, Then Ascending DG3173 Interventions: octreotide and DG3173. 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.
Overall Study STARTED	20
Overall Study Received Octreotide	20
Overall Study Received 100 µg DG3173	20
Overall Study Received 300 µg DG3173	20
Overall Study Received 900 µg DG3173	19
Overall Study Received 1800 µg DG3173	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cross-over n=20 Participants Interventions: octreotide and DG3173. 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.
Age, Continuous	47.8 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Ukraine	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.

Population: Baseline: an 8 hour untreated human growth hormone (hGH) profile was obtained in the period between 15 and 7 days prior to the first study treatment administration.