Dwarfism, Growth Hormone DeficiencyNCT00601419
Drug Use Investigation of Somatropin for GHD-ADULTS.
An observational study of Dwarfism, Growth Hormone Deficiency, run by Pfizer.
Trial summary
Post marketing drug use investigation of Genotropin for GHD-ADULTS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dwarfism, Growth Hormone Deficiency
- What is being tested?
- Somatropin
- Type of treatment
- Injection or infusion
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A6281286 prescribes the Somatropin.
Who may be able to join
- The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".
Who cannot join
- Patients not administered Somatropin.
About this study
Official title: Drug Use Investigation of GENOTROPIN for GHD-ADULTS.
Post marketing drug use investigation of Genotropin for GHD-ADULTS.
Read the detailed description
All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.
- Conditions
- Dwarfism, Growth Hormone Deficiency
- Being tested
- Somatropin
- 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
Genotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg.
Dosage, Frequency: According to Japanese LPD, "The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day".
Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration.
| Study group | Role | What they receive |
|---|---|---|
| Somatropin | Patients administered Somatropin. Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.
Measured: 6 month
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.
Measured: 6 month
Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.
To determine whether age is a significant risk factor in the frequency of treatment related adverse events.
Measured: 6 month
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.
Measured: 6 month
Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.
To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.
Measured: 6 month
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.
Measured: 6 month
Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.
To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.
Measured: 6 month
Proportion of Participants Achieving Clinical Efficacy.
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Measured: 6 month
Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Measured: 6 month
Proportion of Participants Achieving Clinical Efficacy by Gender.
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Measured: 6 month
Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dwarfism, Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601419
- Sponsor's protocol ID
- A6281286
- Status last verified
- Dec 2013
- First submitted
- 15 Jan 2008
- Last updated
- 6 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Morrhaye G, Kermani H, Legros JJ, Baron F, Beguin Y, Moutschen M, Cheynier R, Martens HJ, Geenen V. Impact of growth hormone (GH) deficiency and GH replacement upon thymus function in adult patients. PLoS One. 2009 May 22;4(5):e5668. doi: 10.1371/journal.pone.0005668.
PubMed 19479077
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of GENOTROPIN for GHD-ADULTS.
- ClinicalTrials.gov ID
- NCT00601419
- Acronym / sponsor ID
- A6281286
- Conditions
- Dwarfism, Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 6 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post marketing drug use investigation of Genotropin for GHD-ADULTS.
Detailed description
All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somatropin | – | Drug: SomatropinPatients administered Somatropin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A6281286 prescribes the Somatropin.
Key inclusion criteria (1 listed)
- The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".
Key exclusion criteria (1 listed)
- Patients not administered Somatropin.
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 |
|---|---|---|
| SomatropinGenotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg. Dosage, Frequency: According to Japanese LPD, "The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day". Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration. | Drug | Somatropin |
Primary outcome
Number of Participants With Treatment Related Adverse Events.
Time frame: 6 month
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Time frame: 6 month
Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.
Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.
Time frame: 6 month
To determine whether age is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
Time frame: 6 month
To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.
Time frame: 6 month
To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
Time frame: 6 month
To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.
Time frame: 6 month
To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.
Proportion of Participants Achieving Clinical Efficacy.
Time frame: 6 month
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.
Time frame: 6 month
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Proportion of Participants Achieving Clinical Efficacy by Gender.
Time frame: 6 month
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.
Time frame: 6 month
Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19479077Morrhaye G, Kermani H, Legros JJ, Baron F, Beguin Y, Moutschen M, Cheynier R, Martens HJ, Geenen V. Impact of growth hormone (GH) deficiency and GH replacement upon thymus function in adult patients. PLoS One. 2009 May 22;4(5):e5668. doi: 10.1371/journal.pone.0005668.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Dwarfism, Growth Hormone Deficiency, run by Pfizer.
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 1 inclusion and 1 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Related Adverse Events. (time frame: 6 month). The study lists 11 primary outcomes in all. 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 NCT00601419, which also lists 1 linked publication.
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 6 Feb 2014; AzTrials last refreshed its copy on 8 Nov 2026.