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Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)

This study is currently recruiting participants.
Verified June 2011 by Aarhus University Hospital
Sponsor:
Collaborator:
Novo Nordisk
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01090778
First received: March 22, 2010
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Growth Hormone Deficiency
 Drug: Norditropin SimpleXx (growth hormone)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Pharmacokinetic profiles of growth hormone [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as a bolus in the adult patients with growth hormone deficiency during interval exercise or in supine rest.


Secondary Outcome Measures:
  • Pharmacokinetic profiles of growth hormone [ Time Frame: 60 hours ] [ Designated as safety issue: No ]
    To compare pharmacokinetic profiles of growth hormone administrated subcutaneously (3 mg/day) as an infusion in the adult patients with growth hormone deficiency during interval exercise or in supine rest.


Estimated Enrollment: 8
Study Start Date: October 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A session
Single sc bolus injection without interval exercise
 Drug: Norditropin SimpleXx (growth hormone)
3mg/subject/day over two consecutive days
Other Name: Norditropin® SimpleXx®
Session B
Single sc bolus injection with interval exercise
 Drug: Norditropin SimpleXx (growth hormone)
3mg/subject/day over two consecutive days
Other Name: Norditropin® SimpleXx®
Session C
Continuous sc infusion without interval exercise
 Drug: Norditropin SimpleXx (growth hormone)
3mg/subject/day over two consecutive days
Other Name: Norditropin® SimpleXx®
Session D:
Continuous sc infusion with interval exercise
 Drug: Norditropin SimpleXx (growth hormone)
3mg/subject/day over two consecutive days
Other Name: Norditropin® SimpleXx®

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090778

Contacts
Contact: Jurgita Janukonyte, MD +45 89 49 20 71 jurgitajan22@hotmail.com

Locations
Denmark
Medical Department M, Aarhus University Hospital Recruiting
Aarhus C, Central Denmark Region, Denmark, 8000
Contact: Jurgita Janukonyte, MD     +4589492071     jurgitajan22@hotmail.com    
Principal Investigator: Torben Laursen, professor            
Sub-Investigator: Jurgita Janukonyte, MD            
Aarhus University Hospital Enrolling by invitation
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Novo Nordisk
Investigators
Principal Investigator: Torben Laursen, professor Institute of Pharmacology, Aarhus University
  More Information

No publications provided

Responsible Party: Professor Jens Sandahl Christiansen, Medical Department M, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01090778     History of Changes
Other Study ID Numbers: 2010/0121
Study First Received: March 22, 2010
Last Updated: June 22, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:
growth hormone deficiency
circadian variation

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013