UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032378 |
|---|---|
| Receipt number | R000036906 |
| Scientific Title | Randomized, placebo-controlled, double-blind comparative study of N-Acetylcysteine for the treatment with intervertebral disc degeneration. |
| Date of disclosure of the study information | 2018/04/25 |
| Last modified on | 2023/05/01 21:11:24 |
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Basic information
Public title
Randomized, placebo-controlled, double-blind comparative study of N-Acetylcysteine for the treatment with intervertebral disc degeneration.
Acronym
Comparative study of N-Acetylcysteine for the treatment with intervertebral disc degeneration.
Scientific Title
Randomized, placebo-controlled, double-blind comparative study of N-Acetylcysteine for the treatment with intervertebral disc degeneration.
Scientific Title:Acronym
Comparative study of N-Acetylcysteine for the treatment with intervertebral disc degeneration.
Region
| Japan |
Condition
Condition
Lumbar intervertebral disc degeneration associated with low back pain (containing lumbar disc herniation)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether administration of NAC could prevent further intervertebral disc degeneration associated with low back pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative assessment of disc degeneration using Q-space imaging.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Take NAC (300 mg / tablet) 2 tablets plus take 1 placebo tablet, total 3 tablets once 3 times a day for 24 weeks
Interventions/Control_2
Take NAC (300 mg / tablet) 3 tablets once 3 times a day for 24 weeks
Interventions/Control_3
Take 3 placebo tablets once 3 times a day for 24 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All participants who agree with enrollment in this study and meet all the criteria as bellows;
1) Lumbar intervertebral disc degeneration (Phirrmann grade : 3, 4) or lumbar disc herniation in whom VAS score is over 5.0 point.
2) Regardless of patients with hospitalized or outpatinet.
3) Regardless of disease with primary or recurrence.
4) Agreement to stop anti-inflammatory analgesic except for an approved medicine.
Key exclusion criteria
1) Severe combined complications of heart, liver and blood diseases.
2) Patients with surgical treatment that attending physician consider having impact on the results.
3) Three times higher of AST/ALT before administration of NAC
4) Currently taking NAC or supplement containing NAC.
5) Allergy for NAC
6) Women who are during pregnancy, under lactation, have a possibility to pregnancy, and who hope pregnancy.
7) Previous spine surgery
8) Incompetent patients judged by attending doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nakamura |
| Middle name | |
| Last name | Masaya |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku
TEL
03-3353-1211
masa@keio.jp
Public contact
Name of contact person
| 1st name | Watanabe |
| Middle name | |
| Last name | Kota |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku
TEL
03-3353-1211
Homepage URL
watakota@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self founding
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjyuku-ku
Tel
03-3353-1211
iwatakuji@gmail.com
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 | 04 | Month | 25 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036906
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