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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

Brief 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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: octreotide Drug: DG3173 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Effect of Ascending Single Doses of DG3173 and 300 μg of Octreotide on Human Growth Hormone Levels in Untreated Acromegalics.
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: octreotide
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.

Drug: 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.




Primary Outcome Measures :
  1. Participants With Trough Human Growth Hormone < 2.5 ug/mL [ 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men, women of non childbearing potential or women of child bearing potential who either abstain from sexual intercourse, have a sterile partner or practice a medically approved double barrier method of contraception
  • Diagnosis of acromegaly of pituitary origin
  • Have age adjusted Insulin like Growth Factor 1 (IGF-1) concentrations ≥1.5 times the upper limit of normal range on two consecutive measurements in the 6 months prior to the first dosing day (including the measurement to be made at screening [Visit 2])
  • Have a random hGH level of ≥5 µg/L in the 6 months prior to or at screening (Visit 2)
  • Have given written informed consent
  • Ability to comply with the requirements of the protocol of the study

Exclusion Criteria:

  • Previous specific treatment for acromegaly in the 6 months prior to screening (Visit 2), including somatostatin analogues (SSAs), surgery, radiotherapy and pegvisomant
  • Treatment with dopamine agonists in the 3 months prior to screening (Visit 2)
  • Uncontrolled hypertension or orthostatic hypotension
  • Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated haemoglobin [HbA1c]≥7.5%) and patients requiring insulin treatment
  • Gallstones or gravel that could cause biliary obstruction
  • Hyperprolactinaemia
  • Participation in a clinical study within 60 days prior to screening (Visit 2)
  • Receipt of blood, blood products or plasma derivatives 60 days prior to screening (Visit 2)
  • Pregnancy or lactation
  • A history of active alcohol abuse or drug addiction
  • Positive viral serology screening result for hepatitis B surface antigen, antibodies to hepatitis C virus, or human immunodeficiency virus type 1 and 2
  • Evidence or suspicion of tumour expansion
  • Clinically significant abnormality in screening ECG
  • Any clinically significant abnormal laboratory safety test (biochemistry, haematology and dipstick urinalysis) in the opinion of the Investigator
  • Any disease which in the Investigator's opinion would exclude the patient from the study

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Responsible Party: Aspireo Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT02235987    
Other Study ID Numbers: DG3173-II-01
First Posted: September 10, 2014    Key Record Dates
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents