Trial Outcomes & Findings for The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics (NCT NCT02217800)
NCT ID: NCT02217800
Last Updated: 2018-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
23 hours following each treatment
Results posted on
2018-02-15
Participant Flow
Participant milestones
| Measure |
Saline, Then DG3173, Then Octreotide
Interventions: saline, DG3173 and 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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics
Baseline characteristics by cohort
| Measure |
Saline, Then DG3173, Then Octreotide
n=8 Participants
Interventions: saline, DG3173 and 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.
|
|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 23 hours following each treatmentOutcome measures
| Measure |
Saline (Control)
n=8 Participants
|
920 µg DG3173
n=8 Participants
|
2760 µg DG3173
n=8 Participants
|
5520 µg DG3173
n=8 Participants
|
Active Control (Octreotide)
n=8 Participants
|
|---|---|---|---|---|---|
|
The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment.
|
0 participants with trough hGH < 2.5 µg/mL
|
1 participants with trough hGH < 2.5 µg/mL
|
2 participants with trough hGH < 2.5 µg/mL
|
3 participants with trough hGH < 2.5 µg/mL
|
4 participants with trough hGH < 2.5 µg/mL
|
Adverse Events
Saline (Control)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
920 µg DG3173
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2760 µg DG3173
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
5520 µg DG3173
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Control (Octreotide)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saline (Control)
n=8 participants at risk
|
920 µg DG3173
n=8 participants at risk
|
2760 µg DG3173
n=8 participants at risk
|
5520 µg DG3173
n=8 participants at risk
|
Active Control (Octreotide)
n=8 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
|
General disorders
Pyrexia
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
12.5%
1/8
|
12.5%
1/8
|
25.0%
2/8
|
25.0%
2/8
|
0.00%
0/8
|
|
Vascular disorders
Hypertension
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place