UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042357 |
|---|---|
| Receipt number | R000048352 |
| Scientific Title | OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2025/02/04 19:44:18 |
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Basic information
Public title
OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Acronym
OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Scientific Title
OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Scientific Title:Acronym
OxyContin TR Tablets Specified Drug Use-results Survey in patient with Chronic Pain
Region
| Japan |
Condition
Condition
Chronic Pain
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Collect the safety information of OxyContin TR tablets at dose reduction and at the end of administration (discontinuation) in patients with chronic pain under the actual conditions of use, and evaluate the frequency of the incidence for physiccal dependence and/or the increasing risks for dependence during long term use
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Safety
evaluating drug dependency
Key secondary outcomes
(1) Safety
Incidence rates of adverse drug reactions
(2) Efficacy
Clinical Global Impression-Improvement (CGI-I)
Brief Pain Inventory-Severity of pain, funactional impairment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received OxyContin TR tablets for the first time to relieve chronic pain.
Key exclusion criteria
NA
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Ishii |
Organization
Shionogi Pharma Co., Ltd.
Division name
Regulatory Affairs and Pharmacovigilance Department
Zip code
566-0022
Address
5-1, Mishima 2-chome, Settsu, Osaka 566-0022, Japan
TEL
06-6381-7103
shingo.ishii@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kitano |
Organization
Shionogi Pharma Co., Ltd.
Division name
Regulatory Affairs and Pharmacovigilance Department
Zip code
566-0022
Address
5-1, Mishima 2-chome, Settsu, Osaka 566-0022, Japan
TEL
06-6381-7103
Homepage URL
yoshinori.kitano@shionogi.co.jp
Sponsor or person
Institute
Shionogi Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi Pharma 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
None
Address
None
Tel
None
None
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
| 2020 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
NA
Publication of results
Partially published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
455
Results
In the safety analysis set (376 patients), the incidence of ADRs was 45.48% (171 patients), and the common ADRs were constipation, somnolence, nausea, dizziness, and decreased appetite. There were three patients who exhibited withdrawal syndrome.
In the efficacy analysis set (351 patients), BPI-pain severity (average pain) score as well as BPI-pain interference score (total) were decreased compared to the baseline scores. These data suggest pain relief and improvement in ADL in the patients.
Results date posted
| 2025 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients' characteristics included in the safety analysis (376 patients) were follows.
Gender: Male 183 patients (48.7%), Female 193 patients (51.3%) .
Age: >-65 years 201 patients (53.5%), 15 - 65 years 175 patients (46.5%). No pediatric (below 15 years) patients.
Major cause of chronic pain: chronic low back pain 144 patients (38.3%).
Duration of chronic pain: <1 year 48 patients (12.8%), >-1 year - <2 years 57 patients (15.2%), >-2 years - <5 years 64 patients (17.0%), >-5 years 109 patients (29.0%).
Participant flow
This study was conducted at 330 contract sites, and eligible patients were registered from 200 sites. Case reports were collected from 383 patients who provided informed consent documents.
Based on the guidelines for case management, 376 patients were included in the safety analysis set after excluding 7 patients, while the efficacy analysis set was comprised of 351 patients after excluding 25 patients.
Adverse events
The overall incidence of ADRs was 45.48% (171 patients/total 376 patients). The common ADRs included constipation (21.01%, 79 patients), somnolence (9.57%, 36 patients), nausea (8.78%, 33 patients), dizziness (3.72%, 14 patients), and decreased appetite (2.93%, 11 patients), all of which were predictable from the Precautions for use in the J-PI. Three patients (0.80%) exhibited withdrawal syndrome that is the ADR related to physical dependence. No ADRs related to psychological dependence were reported in this study.
Outcome measures
<Safety Results>
The overall incidence of ADRs was 45.48% (171 patients/total 376 patients). The common ADRs included constipation (21.01%, 79 patients), somnolence (9.57%, 36 patients), nausea (8.78%, 33 patients), dizziness (3.72%, 14 patients), and decreased appetite (2.93%, 11 patients), all of which were predictable from the Precautions for use in the J-PI. Three patients (0.80%) exhibited withdrawal syndrome that is the ADR related to physical dependence. No ADRs related to psychological dependence were reported in this study.
Serious ADRs were observed in 14 patients (8.2%), while 157 patients (91.8%) exhibited non-serious ADRs. Total 17 serious ADRs seen in 14 patients were delirium (14 patients), somnolence (2 patients), pneumonia (1 patient), aspiration pneumonia (1 patient), decreased appetite (1 patient), epilepsy (1 patient), tremor (1 patient), hypoxia (1 patient), ileus (1 patient), nausea (1 patient), vomiting (1 patient), falls (1 patient), and drowning (1 patient). The patient who exhibited pneumonia was in the status of not recovered, whereas the other patient suffered from drowning died due to this ADR. The patients were recovered or improved from the remaining ADRs.
<Efficacy Results>
Changes in BPI-pain severity (average pain) score from the baseline after the initiation of treatment were -2.0 +/- 2.8 (4 weeks), -2.0 +/- 2.7 (12 weeks), -2.0 +/- 2.7 (28 weeks), and -2.1+/- 2.5 (52 weeks) (n = 256). Changes in BPI-pain interference score (total) from the baseline were -9.7 +/- 17.3 (4 weeks), -11.1 +/- 17.8 (12 weeks), -11.4 +/- 15.1 (28 weeks), and -12.5 +/- 18.2 (52 weeks) (n = 214). These data indicate a decrease in scores compared to the baseline at all observation time points after the initiation of treatment, suggesting pain relief and improvement in ADL in the patients. On the CGI-I rating scale at 52 weeks after the initiation of treatment or at the time of withdrawal/termination of treatment, 35.1% of the patients showed marked improvement or moderate improvement (n = 302).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 30 | Day |
Other
Other related information
NA
Management information
Registered date
| 2020 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048352
