UMIN-CTR Clinical Trial

Public title

Multicenter General Clinical Study of TRM-1106 (Phase III)

Acronym

General Clinical Study of TRM-1106

Scientific Title

Multicenter General Clinical Study of TRM-1106 (Phase III)

Scientific Title:Acronym

General Clinical Study of TRM-1106

Region

Japan

Condition

The subjects will be patients with postoperative pain.

Classification by specialty

Surgery in general

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety of TRM-1106 when it is administered repeatedly in patients with moderate or more severe pain at rest within 24 hours after surgery.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety evaluation
(1) Incidence of adverse events (AEs)
(2) Incidence of adverse drug reactions (ADRs; AEs related to the study drug)

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In consideration of the subject's condition, TRM-1106 should be administered during the following period:
Repeated administration at intervals of 6 hours, for 24 hours to 5 days.
(The total number of doses should be four or more, and 20 at maximum.)

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria will be included in this study.
<to be confirmed before surgery>
(1) Patients who are able to consent to participation in this study in writing and continuously participate in this study.
(2) Patients who are scheduled to receive surgeries under systemic, local, spinal, epidural, or combination anesthesia:
(3) Patients who are scheduled to be hospitalized for 24 hours or longer after the first administration of the study drug.
(4) Patients whose physical status is Status 1, 2, or 3 according to the American Society of Anesthesiologists (ASA) Physical Status Classification System.
(5) Patients for whom pain intensity rating can be performed.
<to be performed after the surgery before the first administration of the study drug>
(6) Patients with moderate or more severe pain at rest within 24 hours after surgery.

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

80

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

02

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

02

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

02

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=R000012014