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

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ClinicalTrials.gov Identifier: NCT02235987
Recruitment Status : Completed
First Posted : September 10, 2014
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Aspireo Pharmaceuticals Limited

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acromegaly
Interventions Drug: octreotide
Drug: DG3173
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Octreotide, Then Ascending DG3173
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Received Octreotide 20
Received 100 µg DG3173 20
Received 300 µg DG3173 20
Received 900 µg DG3173 19
Received 1800 µg DG3173 19
Completed 19
Not Completed 1
Arm/Group Title Cross-over
Hide Arm/Group Description 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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
47.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
18
  90.0%
Male
2
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Ukraine Number Analyzed 20 participants
20
1.Primary Outcome
Title Participants With Trough Human Growth Hormone < 2.5 ug/mL
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Baseline (Untreated Control) 300 µg Octreotide 100 µg DG3173 300 µg DG3173 900 µg DG3173 1800 µg DG3173
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20 20 20 19 19
Measure Type: Number
Unit of Measure: participants with trough hGH < 2.5 µg/mL
1 8 4 6 7 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 300 µg Octreotide 100 µg DG3173 300 µg DG3173 900 µg DG3173 1800 µg DG3173
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
300 µg Octreotide 100 µg DG3173 300 µg DG3173 900 µg DG3173 1800 µg DG3173
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
300 µg Octreotide 100 µg DG3173 300 µg DG3173 900 µg DG3173 1800 µg DG3173
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
300 µg Octreotide 100 µg DG3173 300 µg DG3173 900 µg DG3173 1800 µg DG3173
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/20 (5.00%)   0/20 (0.00%)   1/20 (5.00%)   0/19 (0.00%)   1/19 (5.26%) 
Gastrointestinal disorders           
abdominal pain  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/19 (0.00%)  1/19 (5.26%) 
Metabolism and nutrition disorders           
Hyperamylasemia  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/19 (0.00%)  0/19 (0.00%) 
Nervous system disorders           
Encephalopathy  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/19 (0.00%)  0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fredric Cohen, MD
Organization: Strongbridge Biopharma
Phone: 610-254-9200
EMail: f.cohen@strongbridgebio.com
Layout table for additonal information
Responsible Party: Aspireo Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT02235987    
Other Study ID Numbers: DG3173-II-01
First Submitted: August 14, 2014
First Posted: September 10, 2014
Results First Submitted: June 7, 2016
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018