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Trial · Observational

CompletedPhase not statedResults postedRegistry data

Drug Use Investigation of Somatropin for GHD-ADULTS.

NCTNCT00601419 (opens ClinicalTrials.gov in a new tab)Other idA6281286
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
230 participants (actual)
Sponsor
Pfizer · Industry
Design
Not stated
Countries
Not stated
Start
Mar 2007
Primary completion
Dec 2012
Completion
Dec 2012
First posted
28 Jan 2008 (estimated)
Last update posted
6 Feb 2014 (estimated)
Conditions
Dwarfism, Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010201120122013
  1. Ph –

    Drug Use Investigation of Somatropin for GHD-ADULTS.

    NCT00601419

    Mar 2007 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Post marketing drug use investigation of Genotropin for GHD-ADULTS.

Interventions

  • SomatropinDrug

Arms1

  • Other

    Somatropin

    Patients administered Somatropin.

Primary outcomes11

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment Related Adverse Events.

    Time frame · 6 month

    Registry description

    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.

  2. Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

    Time frame · 6 month

    Registry description

    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.

  3. Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.

    Time frame · 6 month

    Registry description

    To determine whether age is a significant risk factor in the frequency of treatment related adverse events.

  4. Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.

    Time frame · 6 month

    Registry description

    To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.

  5. Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.

    Time frame · 6 month

    Registry description

    To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.

  6. 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

    Registry description

    To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.

  7. Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.

    Time frame · 6 month

    Registry description

    To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.

  8. Proportion of Participants Achieving Clinical Efficacy.

    Time frame · 6 month

    Registry description

    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.

  9. Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.

    Time frame · 6 month

    Registry description

    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.

  10. Proportion of Participants Achieving Clinical Efficacy by Gender.

    Time frame · 6 month

    Registry description

    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.

  11. Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.

    Time frame · 6 month

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 month

Number of Participants With Treatment Related Adverse Events.

GroupValue (participants)
Somatropin29
Primary outcomeNumber· 6 month

Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

GroupValue (events)
Somatropin8
Primary outcomeNumber· 6 month

Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.

GroupValue (participants)
<65 Years24
>=65 Years5
Primary outcomeNumber· 6 month

Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.

GroupValue (participants)
Male13
Female16
Primary outcomeNumber· 6 month

Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.

GroupValue (participants)
Participants With TSH Deficiency17
Participants Without TSH Deficiency12
Primary outcomeNumber· 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.

GroupValue (participants)
Participants With Past History of Any Disease17
Participants Without Past History of Any Disease12
Primary outcomeNumber· 6 month

Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.

GroupValue (participants)
<0.021 mg/kg/Week23
>=0.021 mg/kg/Week and <0.042 mg/kg/Week4
>=0.042 mg/kg/Week and <=0.084 mg/kg/Week0
>0.084 mg/kg/Week1
Primary outcomeNumber· 6 month

Proportion of Participants Achieving Clinical Efficacy.

GroupValue (participants)
Somatropin185

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SomatropinParticipants taking somatropin for adult growth hormone deficiency according to Japanese package insert.–10 / 22619 / 226

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedMorrhaye 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. PMID 19479077

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)". Exclusion Criteria: Patients not administered Somatropin.

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