Growth Hormone DisorderPhase 4NCT01562834
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
A Phase 4 study testing somatropin in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 24 sites in France.
Trial summary
This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency
- What is being tested?
- somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 24 sitesFrance
- Study dates
- 21 Oct 1998to 1 Dec 2002
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Childhood or adult onset growth hormone deficiency (GHD)
- GHD evidenced by two stimulation tests
- Duration of GHD at least 5 years
- Other hormone deficiencies associated with growth hormone deficiency
Who cannot join
- Pregnancy or pregnancy desired during the suggested duration of the study
- Personal history of colonic polyp or family history of colonic polyposis
- Known insulin-dependent or non-insulin-dependent diabetes
- Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
- BMI (Body Mass Index) at least 30
- Growth hormone treatment during the 24 months prior to inclusion, history of treatment with extractive pituitary growth hormone, allergy or suspected allergy to somatropin therapy
Show all 9Show fewer
- Patient who has participated in a different clinical study within the past two months
- Any condition which, in the opinion of the Investigator or the Scientific Committee, may interfere with successful implementation of the study
- Notion of breast cancer for the mother or the sister
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Novo Nordisk Investigational Site
Angers, 49033
Novo Nordisk Investigational Site
Boisguillaume, 76233
Novo Nordisk Investigational Site
Brest, 29609
Novo Nordisk Investigational Site
Caen, 14033
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, 94275
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Lorient, 56322
Novo Nordisk Investigational Site
Lyon, 69394
Novo Nordisk Investigational Site
Lyon, 69437
Novo Nordisk Investigational Site
Marseille Cédex 05, 13385
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Nantes, 44000
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Nice, 06002
Novo Nordisk Investigational Site
Paris, 75010
Novo Nordisk Investigational Site
Paris, 75015
Novo Nordisk Investigational Site
Paris, 75571
Novo Nordisk Investigational Site
Reims, 51092
Novo Nordisk Investigational Site
Rennes, 35056
Novo Nordisk Investigational Site
Strasbourg, 67098
Novo Nordisk Investigational Site
Toulouse, 31054
Novo Nordisk Investigational Site
Tours, 37044
Novo Nordisk Investigational Site
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients
This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
- Being tested
- somatropin, placebo
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.
placeboDrug
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Somatropin | Experimental | Not described Receives: Drug: somatropin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass measured with ultrasonography
Secondary outcomes (4)
Ventricular function indices assessed by cardiac ultrasonography
Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)
Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales
IGF-I (Insulin-Like Growth Factor I) concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study start21 Oct 1998
- Primary completion1 Dec 2002
- Study completion1 Dec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562834
- Sponsor's protocol ID
- GHDADULT/F/1/F
- Status last verified
- Feb 2024
- First submitted
- 22 Mar 2012
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients
- ClinicalTrials.gov ID
- NCT01562834
- Acronym / sponsor ID
- GHDADULT/F/1/F
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 1998 (actual)
- Primary completion
- 1 Dec 2002 (actual)
- Study completion
- 1 Dec 2002 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatropin | Experimental | Drug: somatropin |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Childhood or adult onset growth hormone deficiency (GHD)
- GHD evidenced by two stimulation tests
- Duration of GHD at least 5 years
- Other hormone deficiencies associated with growth hormone deficiency
Key exclusion criteria (9 listed)
- Pregnancy or pregnancy desired during the suggested duration of the study
- Personal history of colonic polyp or family history of colonic polyposis
- Known insulin-dependent or non-insulin-dependent diabetes
- Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent auricular or ventricular arrhythmia, history of vascularisation by aortocoronary bypass significative mitral or aortic valvular disease, preexcitation syndrome, auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left ventricular mass interfering treatment
- BMI (Body Mass Index) at least 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatropinInitial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin. | Drug | Somatropin |
| placeboInitial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued. | Drug | Placebo |
Primary outcome
Left ventricular mass measured with ultrasonography
4 secondary outcomes
Ventricular function indices assessed by cardiac ultrasonography
Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)
Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales
IGF-I (Insulin-Like Growth Factor I) concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing somatropin in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 24 sites in France.
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 4 inclusion and 9 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Left ventricular mass measured with ultrasonography. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.