UMIN-CTR Clinical Trial

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

The subjects will be patients with postoperative pain.

Classification by specialty

Orthopedics

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Efficacy Evaluation
(1) Pain intensity
(2) Pain relief
(3) Overall assessment
(4) Rescue analgesics- Pharmacokinetics

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

Institute

Terumo Corporation

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

04

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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