UMIN-CTR Clinical Trial

Public title

A Japanese, multicenter, randomized, double-blind, placebo-controlled, prospective study of AT-02 in patients with fibromyalgia

Acronym

A Japanese, multicenter, randomized, double-blind, placebo-controlled, prospective study of AT-02 in patients with fibromyalgia

Scientific Title

A Japanese, multicenter, randomized, double-blind, placebo-controlled, prospective study of AT-02 in patients with fibromyalgia

Scientific Title:Acronym

A Japanese, multicenter, randomized, double-blind, placebo-controlled, prospective study of AT-02 in patients with fibromyalgia

Region

Japan

Condition

Fibromyalgia

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of AT-02 in patients newly diagnosed with fibromyalgia or patients who have been diagnosed with fibromyalgia and treated with medical intervention in comparison with Sham control (S-01)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The difference between the mean NRS in the Baseline Observation Period (6 days from Day -2 to Day 7 of the Baseline Observation Period) and the mean NRS at Week 8 of the Treatment Period

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

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

Device,equipment

Interventions/Control_1

(1) AT-02 group
AT-02 is an investigational medical device (unapproved) that concurrently produces multiple magnetic fields to promote pain relief.

Interventions/Control_2

(2) S-01 Sham group (Sham Control)
A device that is inactive and does not produce magnetic fields, although it is completely indistinguishable from AT-02 (e.g., appearance, form, weight)

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

79

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Age:Patients aged 20 years of age or older - <80 years (at the time of obtaining informed consent)
(2)Patients meeting the diagnostic criteria for fibromyalgia (1990) from the American College of Rheumatology (ACR)
(3)Patients with NRS 4 or more and persistent pain for 3 months or longer
(4)Patients from whom written informed consent can be directly obtained

Key exclusion criteria

(1) Patients with expected survival less than 3 years due to malignancies or other reasons
(2) Patients using life-sustaining electrical medical devices, such as artificial heart-lung devices
(3) Patients using affixed electrical medical devices, such as ECG recorders
(4) Patients who are participating in another clinical trial for a pharmaceutical product or medical device
(5) Patients with dementia that seriously disturbs activities of daily life
(6) Females who wish to become pregnant or are presently pregnant or nursing mothers (if the patient is a woman of childbearing potential, a pregnancy test must be performed) and others.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Iwao Kishita

Organization

P-Mind Co. Ltd.

Division name

President

Zip code

Address

3-37-24, Takahira, Kita-ku, Kumamoto City, Kumamoto, 860-0085

TEL

096-345-6600

Email

kishita.2011.1.11@p-mind.co.jp

Name of contact person

1st name
Middle name
Last name	Makoto Sawaguchi

Organization

Mebix Inc.

Division name

Research Promotion Division

Zip code

Address

1-11-44, Akasaka, Minato-ku, Tokyo, 107-0052

TEL

03-4362-4500

Homepage URL

Email

angel@mebix.co.jp

Institute

P-Mind Co. Ltd.

Institute

Department

Personal name

Organization

P-Mind Co., Ltd.

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

2016

Year

09

Month

12

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

Completed

Date of protocol fixation

2016

Year

08

Month

08

Day

Date of IRB

Anticipated trial start date

2016

Year

09

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

12

Day

Last modified on

2017

Year

06

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027632