The Effect of Subcutaneous Infusions of… | Clinical Trial

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception
Diagnosis of acromegaly of pituitary origin
Have an age-adjusted insulin-like growth factor type 1 (IGF-1) concentration ≥1.2 times the upper limit of normal range on at least one measurement in the 12 months prior to screening (Visit 1) AND a second raised value screening
Have at least one random hGH level of ≥5 μg/L in the 12 months prior to screening AND a second raised value at screening
Have given written informed consent
Ability to comply with the requirements of the protocol for the study

Exclusion criteria

Previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (SSAs); surgery; radiotherapy and pegvisomant
Treatment with dopamine agonists in the 3 months prior to screening
Uncontrolled hypertension
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
Receipt of blood, blood products or plasma derivatives 60 days prior to screening
Body mass index (BMI) below 22 or above 37 kg/m2
Pregnancy, lactation or use of any hormonal based contraceptives
Concomitant intake of corticosteroids or levodopa
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 in the opinion of the Investigator
Any clinically significant abnormal in screening 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

Treatment and study plan

Saline

Drug

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.

DG3173

Drug

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.

Octreotide

Drug

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.

Primary outcomes

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.

Time frame: 23 hours following each treatment

Sponsors and collaborators

Lead sponsor

Aspireo Pharmaceuticals Limited

Industry

Registry information

Official study title

The Effect of Subcutaneous Infusions of 3 Doses of a Novel Somatostatin Analogue, DG3173, on Growth Hormone Levels in Untreated Acromegalics

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2016
First posted: Aug 15, 2014
Registry last updated: Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed