Clinical Trial Results:
A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults
Summary
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EudraCT number |
2004-004835-72 |
Trial protocol |
GB |
Global end of trial date |
23 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Aug 2020
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First version publication date |
28 Aug 2020
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Other versions |
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Summary report(s) |
Summary 2004-004835-72 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RG_05-161
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University of Birmingham
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Sponsor organisation address |
Edgbaston, Birmingham, United Kingdom, B15 2TT
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Public contact |
Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
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Scientific contact |
Research Governance Team, University of Birmingham, researchgovernance@contacts.bham.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Oct 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Oct 2013
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To determine the impact of growth hormone replacement therapy on quality of Life in adults with severe growth hormone deficiency
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Protection of trial subjects |
Inclusion criteria:
Aged over 18
Able to provide informed consent
Severe GH deficiency in adult life
No GH replacement therapy for six months
Other hormone replacement therapy stable over previous six months
Life expectancy >15 months
Exclusion criteria:
Active malignant disease
Active Cushings disease or acromegaly
Pregnancy
Proliferative diabetic retinopathy
Sensitivity to GH or its preservative
Breast feeding
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 May 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 88888
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Worldwide total number of subjects |
88888
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EEA total number of subjects |
88888
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
88888
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Recruitment
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Recruitment details |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues. | ||||||
Pre-assignment
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Screening details |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues. | ||||||
Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||
Roles blinded |
Subject, Investigator | ||||||
Blinding implementation details |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
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Arms
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Arm title
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Overall | ||||||
Arm description |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues. | ||||||
Arm type |
n/a | ||||||
Investigational medicinal product name |
Growth Hormone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
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Baseline characteristics reporting groups
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Reporting group title |
Overall
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Reporting group description |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues. | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Overall
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Reporting group description |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues. |
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End point title |
Not applicable [1] | ||||||
End point description |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues.
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End point type |
Primary
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End point timeframe |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses have been specified as the trial was terminated early. After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues. |
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Notes [2] - 88888 is referring to not applicable due to the data integrity issues. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
n/a | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events have been specified as the trial was terminated early. After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. For the purposes of data entry 88888 is referring to not applicable due to the data integrity issues. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
After a regulatory inspection the trial was closed as the inspection identified issues with data integrity. Our Clinical Trials Oversight Committee have made a decision that these results should not be in the public domain. |