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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01090778
• Date of registration: 22/03/2010
• Prospective Registration: Yes
• Primary sponsor: Aarhus University Hospital
• Public title: Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
• Scientific 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
• Date of first enrolment: October 2010
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01090778
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Torben Laursen, professor
• Affiliation: Institute of Pharmacology, Aarhus University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: Norditropin SimpleXx (growth hormone)

Primary Outcome(s)

Pharmacokinetic profiles of growth hormone [Time Frame: 48 hours]

Secondary Outcome(s)

Pharmacokinetic profiles of growth hormone [Time Frame: 60 hours]

Secondary ID(s)

2010/0121

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novo Nordisk A/S