UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008594 |
|---|---|
| Receipt number | R000007619 |
| Scientific Title | Open label study of analgesic property of minocycline for nociceptive/inflammatory pain and neuropathic pain |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2023/02/08 12:05:50 |
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Basic information
Public title
Open label study of analgesic property of minocycline for nociceptive/inflammatory pain and neuropathic pain
Acronym
Analgesic property of minocycline
Scientific Title
Open label study of analgesic property of minocycline for nociceptive/inflammatory pain and neuropathic pain
Scientific Title:Acronym
Analgesic property of minocycline
Region
| Japan |
Condition
Condition
Nociceptive/Inflammatory pain and Neuropathic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic pain conditions, including nociceptive/inflammatory and neuropathic pain, are refractory to conventional medications. It is caused by activation of microglias in the spinal dorsal horn. Minocycline has a property to prevent the activation of microglias, and we confirm the analgesic property of minocycline in the present study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
an 11-point numeric rating scale of pain intensity
Key secondary outcomes
Total scores of the McGill Pain Questionnaire (Japanese version) and Brief Pain Inventory (Japanese version)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
minocycline
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with nociceptive and/or inflammatory pain
Key exclusion criteria
patients with rheumatoid arthritis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo Hospital
Division name
Department of Pain and Palliaitve medicine
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-3815-5411
sumitanim-ane@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology and Pain Relief Center
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-3815-5411
Homepage URL
sumitanim-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
Hongo 7-3-1 Bunkyo Tokyo
Tel
03-3815-5411
sumitanim-ane@h.u-tokyo.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
| 2012 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/25700217/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/25700217/
Number of participants that the trial has enrolled
20
Results
There was no significant improvement in the scoring of NRS ( P =.60). The total score of the SF-MPQ decreased significantly (P =.02), particularly in the affective subscale (P =.007) but not so in the sensory subscale (P =.06). We conclude that minocycline failed to decrease pain intensity but succeeded in reducing the affective dimension associated with neuropathic pain.
Results date posted
| 2023 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Recent understanding of the neuron-glia communication shed light on an important role of microglia to develop neuropathic pain The analgesic effect of minocycline on neuropathic pain is promising but it remains unclear in clinical settings. This study included 20 patients with neuropathic pain of varied etiologies. We administered 100 mg/day of minocycline for 1 week and then 200 mg/day for 3 weeks, as an open-label adjunct to conventional analgesics. An 11-point numerical rating scale. (NRS) and the short-form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain severity. The data were collected at baseline and after 4 weeks of therapy and analyzed using the Wilcoxon signed-rank test. All except two of the patients tolerated the full dose of minocycline.
Participant flow
Recent understanding of the neuron-glia communication shed light on an important role of microglia to develop neuropathic pain The analgesic effect of minocycline on neuropathic pain is promising but it remains unclear in clinical settings. This study included 20 patients with neuropathic pain of varied etiologies. We administered 100 mg/day of minocycline for 1 week and then 200 mg/day for 3 weeks, as an open-label adjunct to conventional analgesics. An 11-point numerical rating scale. (NRS) and the short-form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain severity. The data were collected at baseline and after 4 weeks of therapy and analyzed using the Wilcoxon signed-rank test. All except two of the patients tolerated the full dose of minocycline.
Adverse events
We conclude that minocycline failed to decrease pain intensity but succeeded in reducing the affective dimension associated with neuropathic pain.
Outcome measures
An 11-point numerical rating scale. (NRS) and the short-form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain severity. The data were collected at baseline and after 4 weeks of therapy and analyzed using the Wilcoxon signed-rank test. All except two of the patients tolerated the full dose of minocycline.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007619
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