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Growth Hormone DeficiencyPhase 2NCT01090778

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

A Phase 2 study testing Norditropin SimpleXx (growth hormone) in people with Growth Hormone Deficiency, run by Aarhus University Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Growth Hormone Deficiency
What is being tested?
Norditropin SimpleXx (growth hormone)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesDenmark
Study dates
Oct 2010to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 %
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Medical Department M, Aarhus University Hospital

    Aarhus C, Central Jutland, 8000

  • Aarhus University Hospital

    Aarhus C, 8000

Other trials in Denmark

About this study

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

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

Read the 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.

Being tested
Norditropin SimpleXx (growth hormone)
Keywords
growth hormone deficiency, circadian variation
Medical subject headings
Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Norditropin SimpleXx (growth hormone)Drug

    Also called Norditropin® SimpleXx®

    3mg/subject/day over two consecutive days

Study groups in NCT01090778
Study groupRoleWhat they receive
Norditropin SimpleXx sc bolus injectionOtherSingle sc bolus injection of 3 mg growth hormone without interval exercise
Receives: Drug: Norditropin SimpleXx (growth hormone)
Norditropin SimpleXx single sc injectionOtherSingle sc bolus injection of 3 mg growth hormone with interval exercise
Receives: Drug: Norditropin SimpleXx (growth hormone)
Norditropin SimpleXx contin. sc infusionOtherContinuous sc infusion of 3 mg growth hormone without interval exercise
Receives: Drug: Norditropin SimpleXx (growth hormone)
Norditropin SimpleXx cont. sc infusionOtherContinuous sc infusion of 3 mg growth hormone with interval exercise
Receives: Drug: Norditropin SimpleXx (growth hormone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic profiles of growth hormone

    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.

    Measured: 48 hours

Secondary outcomes (1)

  1. Pharmacokinetic profiles of growth hormone

    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.

    Measured: 60 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01090778
Sponsor's protocol ID
2010/0121
Status last verified
Jan 2014
First submitted
22 Mar 2010
Last updated
9 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Norditropin SimpleXx (growth hormone) in people with Growth Hormone Deficiency, run by Aarhus University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic profiles of growth hormone (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01090778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.

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