Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
Information source: Aarhus University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Norditropin SimpleXx (growth hormone) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Aarhus University Hospital Official(s) and/or principal investigator(s):
Torben Laursen, professor, Principal Investigator, Affiliation: Institute of Pharmacology, Aarhus University
Summary
This is an exploratory trial with four cross-over arms measuring the pharmacokinetic and
pharmacodynamic profiles of growth hormone using two different modes of growth hormone
administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in
the thigh) in 8 adult male or female patients with growth hormone deficiency during interval
exercise or in supine rest. The order of dosing regimen within the groups and between the
groups will be randomised. All patients will go through four different treatment
sessions: A/B Single subcutaneous bolus injection, supine rest without/with interval
exercise, sessions C/D: Continuous subcutaneous infusion, supine rest without/with interval
exercise. Hypotheses: 1) There is day-to-day variation of exogenous growth hormone,
2)Concentration of growth hormone decreases due to exercise compared to supine rest, 3)There
is a circadian variation in pharmacokinetics of exogenous growth hormone infused
subcutaneously
Clinical Details
Official title: Pharmacokinetic Profiles of GH Using Two Different Administration Regimes; a Bolus and an Infusion Both With and Without Exercise, in Adults With Growth Hormone Deficiency
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetic profiles of growth hormone
Secondary outcome: Pharmacokinetic profiles of growth hormone
Detailed description:
The subjects will attend a screening visit and four treatment sessions. The dosing visits
will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital
stay for the infusion group.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- AGHD male or female subjects
- Stable GH replacement therapy for at least 3 months
- Body Mass Index 18,5 to 35. 0 kg/m2
- Achieved final height
- Age ≥ 18 years
Exclusion Criteria:
- Known or suspected allergy to trial product or components of the trial product
- Subjects with active malignancy
- Severe cardiac insufficiency classified according to NYHA III-IV
- Unstable angina pectoris, acute myocardial infarction within the last 12 months
- Severe, uncontrolled hypertension: sitting blood pressure > 180/110 mmHg
- HbA1C > 7,5 %
- Impaired kidney function: plasma creatinine ≥ 150 umol/l according to the hospital
lab.
- Impaired liver function: liver parameters exceed 2 times or more the upper normal
limit, according to the hospital lab.
- Patients on insulin treatment
- Stable pituitary replacement therapy for less than 3 months
- Participation in any other clinical trial involving any investigational products
within the last three months prior to this trial
- Any diseases judged by the investigator that could affect the trial
- Women of fertile age, who are pregnant, planning to become pregnant or
breast-feeding. Women of fertile age, who are not currently using adequate
contraception methods such as: contraceptive pills, IUD or who had not undergone
hysterectomy or sterilization
Locations and Contacts
Aarhus University Hospital, Aarhus C 8000, Denmark
Medical Department M, Aarhus University Hospital, Aarhus C, Central Denmark Region 8000, Denmark
Additional Information
Starting date: October 2010
Last updated: January 8, 2014
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