UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022507 |
|---|---|
| Receipt number | R000025943 |
| Scientific Title | Pregabalin prescription in terminally ill cancer patients receiving specialist palliative care in acute hospital |
| Date of disclosure of the study information | 2016/05/28 |
| Last modified on | 2016/05/28 12:30:22 |
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Basic information
Public title
Pregabalin prescription in terminally ill cancer patients receiving specialist palliative care in acute hospital
Acronym
Pregabalin prescription in terminally ill cancer patients
Scientific Title
Pregabalin prescription in terminally ill cancer patients receiving specialist palliative care in acute hospital
Scientific Title:Acronym
Pregabalin prescription in terminally ill cancer patients
Region
| Japan |
Condition
Condition
Neuropathic cancer-related pain
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pregabalin is recommended as an adjuvant analgesic for neuropathic cancer-related pain, and may be taken at all steps of the World Health Organization analgesic ladder. However, unlike opioids, pregabalin treatments are limited to an oral administration route. If patients have oral feeding difficulties, it is not possible to administer any drug as an adjuvant analgesic for neuropathic cancer-related pain. Therefore, the aim of the present study was to clarify the current status of pregabalin treatments for terminally ill cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Information including the prescriber, reasons for the prescription, initial dose, maintenance dose, administration period, weight, creatinine clearance (Ccr) calculated from the Cockcroft-Gault formula, if pregabalin had been discontinued, the reason for its discontinuation, and the dose of opioid drugs before and after the discontinuation of pregabalin was extracted from the electronic medical records of patients prescribed pregabalin.We investigated the dose of opioids administered before and after the discontinuation of pregabalin. The half-life of pregabalin according to renal function is 5-48 hours, as stated on the package insert. Therefore, based on its excretion from the body, patients who survived 4 days or more after the discontinuation of pregabalin were targeted.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Our subjects comprised cancer patients who died during their hospital stay.
Key exclusion criteria
Not applicable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuya Ise |
Organization
Nippon Medical School Hospital
Division name
Section of Pharmaceutical Services
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
+81-3-3822-2131
yuyaise@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Yajima |
Organization
Nippon Medical School Hospital
Division name
Section of Pharmaceutical Services
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
+81-3-3822-2131
Homepage URL
r-yajima@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Practical Pharmacy, Keio University Faculty of Pharmacy
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Data sources and procedures
The method used in the present study was a chart review. Subjects comprised patients with cancer who were referred between April 1, 2013 and October 31, 2015 to the palliative care team of the 899-bed Cancer Hospital at the Nippon Medical School Hospital in Japan. Inclusion criteria were: a diagnosis of incurable advanced cancer and patients who died during their hospital stay at Nippon Medical School Hospital.
2.Demographic and patient clinical data
Information including age, sex, the date of admission, date of death, primary cancer site, bone metastases, requested reasons for palliative care, performance status (PS) at the time of the palliative care intervention, and a prescription for pregabalin was extracted from the electronic medical records of each patient.
3.The current status of pregabalin treatments
Information including the prescriber, reasons for the prescription, initial dose, maintenance dose, administration period, weight, creatinine clearance (Ccr) calculated from the Cockcroft-Gault formula, if pregabalin had been discontinued, the reason for its discontinuation, and the dose of opioid drugs before and after the discontinuation of pregabalin was extracted from the electronic medical records of patients prescribed pregabalin.
We investigated the dose of opioids administered before and after the discontinuation of pregabalin. The half-life of pregabalin according to renal function is 5-48 hours, as stated on the package insert. Therefore, based on its excretion from the body, patients who survived 4 days or more after the discontinuation of pregabalin were targeted.
The initial and maintenance doses were compared to doses on the package insert.
Management information
Registered date
| 2016 | Year | 05 | Month | 28 | Day |
Last modified on
| 2016 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025943
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| Registered date | File name |
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