UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010440 |
|---|---|
| Receipt number | R000012207 |
| Scientific Title | Multicenter Pivotal Clinical Study of TRM-1106 (Phase III) |
| Date of disclosure of the study information | 2013/04/08 |
| Last modified on | 2013/12/25 10:13:44 |
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Basic information
Public title
Multicenter Pivotal Clinical Study of TRM-1106 (Phase III)
Acronym
Pivotal Clinical Study of TRM-1106
Scientific Title
Multicenter Pivotal Clinical Study of TRM-1106 (Phase III)
Scientific Title:Acronym
Pivotal Clinical Study of TRM-1106
Region
| Japan |
Condition
Condition
The subjects will be patients with postoperative pain.
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the Efficacy of TRM-1106 compared with placebowhen it is administered repeatedly in patients with postoperative pain following total hip.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy Evaluation
(1) Pain intensity
(2) Pain relief
(3) Overall assessment
(4) Rescue analgesics- Pharmacokinetics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
TRM-1106 should be administered repeateadly at intervals of 6 hours, for 24 hours(total 4 administration)
Interventions/Control_2
Placebo should be administered repeateadly at intervals of 6 hours, for 24 hours(total 4 administration)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<to be confirmed before surgery>
(1)subject aged at least 20 years (at the date of signing the consent form)
(2)Patients who are able to consent to participation in this study in writing and continuously participate in this study.
(3) Patients who are scheduled to receive surgeries under systemic, local, spinal, or combination anesthesia:
(4)Subject with a body mass index (BMI) between 18.0 and 35.0.
(5)Patients whose physical status is Status 1, 2, or 3 according to the American Society of Anesthesiologists (ASA) Physical Status Classification System.
(6)Patients for whom pain intensity rating can be performed.
<to be performed after the surgery before the first administration of the study drug>
(7)Patients with moderate or more severe pain at rest ftom 6:00 to 16:00 in 1 postoperative day.
Key exclusion criteria
For the following criteria (1) to (9), the investigator or sub-investigator will determine whether the patient is to be excluded based on the reference.
<before surgery>
(1) Patients resistant to opioids.
(2) Patients with a history of alcohol addiction or drug abuse within the past 1 year.
(3) Patients with hepatic dysfunction.
Reference: ALT or AST is more than double the upper limit of the site, and total bilirubin or prothrombin time is more than double the upper limit of the site.
(4) Patients with hepatic disease (hepatic cirrhosis or hepatitis) and whose ALT or AST is more than double the upper limit of the site or who are determined to have an increased risk of hepatotoxicity after administration of the study drug.
(5) Patients with a past history of hypersensitivity or allergy to any of the ingredients of the study drug, or patients who experienced no therapeutic effects for acetaminophen in the past.
(6) Patients who have peptic ulcer or a past history of peptic ulcer, or patients who have asthma or a past history of asthma.
(7) Patients with a serious blood disorder, renal disorder, or cardiac dysfunction.
(8) Patients who have aspirin-induced asthma or a past history of aspirin-induced asthma.
(9) Hypertensive patients resistant to drug therapy.
Reference: Systolic blood pressure 160 mm Hg or above or diastolic blood pressure 100 mm Hg or above.
(10) Pregnant or lactating women.
(11) Patients who participated in other clinical study within 6 months before the start of this study.
(12) Patients who are determined by the investigator or sub-investigator to be ineligible for participation in this study.
<after surgery before the first administration of the study drug>
(13) Patients treated with any of the prohibited concomitant drugs specified in this protocol.
(14) Patients who need be treated with an antipyretic.
(15) Patients who are scheduled or expected to receive other surgery during the study period.
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Setsuro Ogawa |
Organization
Nihon University Scool of Medicine
Division name
Division of Anesthesiology, Department of Anetesiology
Zip code
Address
30-1 Oyaguchikamicho Itabashi-ku, Tokyo 173- 8610
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamamoto |
Organization
Terumo Corporation
Division name
Clinical Developement Department
Zip code
Address
1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Terumo Corporation
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
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
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
| 2013 | Year | 04 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 08 | Day |
Last modified on
| 2013 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012207
