UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048580 |
|---|---|
| Receipt number | R000055357 |
| Scientific Title | Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2022/08/04 11:32:00 |
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Basic information
Public title
Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Acronym
Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Scientific Title
Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Scientific Title:Acronym
Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Region
| Japan |
Condition
Condition
Adult growth hormone deficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of a long-acting human growth hormone analogue, Somapacitan, on quality of life and quality of sleep in patients with adult growth hormone deficiency (AGHD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Athens Insomnia Scale score before and after starting or changing Somapacitan
Key secondary outcomes
1) Change in SF-36 score before and after starting or changing Somapacitan
2) Change in blood examination before and after starting or changing Somapacitan
3) Change in body composition before and after starting or changing Somapacitan
4) Adverse events during the observation period
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with AGHD requiring Somapacitan therapy
(2) Patients who are 20 years of age or older at the time of obtaining consent
(3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on their full understanding of the study.
Key exclusion criteria
(1) Patients with contraindications to Somapacitan
(2) Other subjects deemed inappropriate as research subjects by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Department of Internal Medicine, Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology
Zip code
8891692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL
0985859121
hideki_yamaguchi@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Uchida |
Organization
Department of Internal Medicine, Faculty of Internal Medicine, University of Miyazaki
Division name
Division of Hematology, Diabetes, and Endocrinology
Zip code
8891692
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL
0985859121
Homepage URL
taisuke_uchida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Faculty of Internal Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
Tel
0985859121
rinken@med.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtaining consent
Research subjects will be selected based on the selection and exclusion criteria.
The investigator will obtain written consent.
Baseline Examination
Baseline laboratory tests will be the values prior to the start of Somapacitan.
In addition to blood tests, body composition (using InBody720), quality of life questionnaire (using SF-36), and sleep questionnaire (using AIS) will be administered to study subjects at baseline.
Observation point 4 weeks
Four weeks after the observation start date, an observation point will be established. Quality of life questionnaires, sleep assessment questionnaires, and body composition test will be administered in addition to blood tests.
Observation point 8 weeks
Eight weeks after the observation start date, an observation point will be established. Sleep assessment questionnaires and body composition test will be administered in addition to blood tests.
Observation point 12 weeks
Twelve weeks after the observation start date, an observation point will be established. Quality of life questionnaires, sleep assessment questionnaires, and body composition test will be administered in addition to blood tests. The allowable range for the 12-week observation point is 12 to 24 weeks.
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055357
