UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033858 |
|---|---|
| Receipt number | R000038609 |
| Scientific Title | Data analysis study of pain in patients with neuromyelitis optica using patient survey data in north America |
| Date of disclosure of the study information | 2018/08/23 |
| Last modified on | 2022/06/06 17:25:11 |
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Basic information
Public title
Data analysis study of pain in patients with neuromyelitis optica using patient survey data in north America
Acronym
Data analysis study of pain in patients with neuromyelitis optica using patient survey data in north America (GJ-2nd)
Scientific Title
Data analysis study of pain in patients with neuromyelitis optica using patient survey data in north America
Scientific Title:Acronym
Data analysis study of pain in patients with neuromyelitis optica using patient survey data in north America (GJ-2nd)
Region
| Japan |
Condition
Condition
Neuromyelitis Optica
Classification by specialty
| Neurology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe pain in patients with neuromyelitis optica by a secondary data analysis of the patient survey conducted by Guthy Jackson Charitable Foundation
Basic objectives2
Others
Basic objectives -Others
The effects of pain on quality of life in patients with neuromyelitis optica
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effects of pain on quality of life in patients with neuromyelitis optica
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with neuromyelitis optica
Key exclusion criteria
Lives in neither the United States nor Canada.
Target sample size
193
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Haramura |
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Division name
Medical affairs Div.
Zip code
1038324
Address
2-1-1 Nihonbashi-Muromachi Chuo-ku, tokyo
TEL
03-3273-2613
haramuramsy@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Haramura |
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Division name
Medical affairs Div.
Zip code
1038324
Address
2-1-1 Nihonbashi-Muromachi Chuo-ku, Tokyo
TEL
03-3273-2613
Homepage URL
mitsutake.asako94@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
not applicable
Address
not applicable
Tel
not applicable
not applicable
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
| 2018 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34252701/
Number of participants that the trial has enrolled
193
Results
Pain severity was the strongest negative predictor of QoL. In the total and AQP4-IgG-seropositive groups, pain was the most common symptom that patients wanted their physician to be concerned about; in the AQP4-IgG-seronegative group, this was fatigue. For all patients, frequent hospital visits and relapses were associated with more severe pain, but not frequency of NMOSD specialist visits. Patients without recent relapse still commonly reported moderate or severe pain (>25%).
Results date posted
| 2022 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 19 | Day |
Baseline Characteristics
The study population was predominantly female (88.6%) and aged 19-76 years.
Participant flow
Results were reported for three groups: AQP4-IgG-seropositive (61.1%), AQP4-IgG-seronegative and the total cohort including patients with unknown serostatus.
Adverse events
-
Outcome measures
We measured the strength of associations and interactions between pain and variables including QoL, patient satisfaction, frequency of hospital visits, and number of relapses versus other symptoms.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We plan to assess the effects of pain on quality of life in patients with neuromyelitis optica
Management information
Registered date
| 2018 | Year | 08 | Month | 22 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038609
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