UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056391 |
|---|---|
| Receipt number | R000064430 |
| Scientific Title | Efficacy and Safety of Lidocaine Ointment for Cancer Skin-Related Pain |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/06/03 19:53:49 |
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Basic information
Public title
Efficacy and Safety of Lidocaine Ointment for Cancer Skin-Related Pain
Acronym
Lidocaine Ointment for Cancer Skin-Related Pain
Scientific Title
Efficacy and Safety of Lidocaine Ointment for Cancer Skin-Related Pain
Scientific Title:Acronym
Lidocaine Ointment for Cancer Skin-Related Pain
Region
| Japan |
Condition
Condition
Cancer skin-related pain
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of lidocaine ointment for cancer skin-related pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients with at least 50% improvement in worst pain intensity NRS in the last 24 hours after the first 72 hours of application
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application of 2% lidocaine ointment
Interventions/Control_2
Application of placebo ointment
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
1) Histopathological or clinical diagnosis of solid cancer.
2) Patient has cancer pain due to cancer skin-related pain (e.g., cancer skin infiltration pain).
(3) Worst pain intensity NRS of cancer skin-related pain in the last 24 hours is 4 or more.
Key exclusion criteria
1) Patients with drug allergy to amide-type local anesthetics.
(2) Patients whose regularly administered analgesic agent has been changed within 24 hours prior to enrollment.
3) Patients who are receiving radiotherapy for tumors with cancer skin-related pain.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5731010
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
TEL
0728040101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
TEL
0728040101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
Tel
0728040101
hasuohid@hirakata.kmu.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
| 2025 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064430
