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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034318
Receipt No. R000039123
Scientific Title Non-inferiority study of GM142 compared to Seprafilm in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery -Multicenter, randomized, single blind, parallel-group comparison study-
Date of disclosure of the study information 2018/10/01
Last modified on 2018/10/17

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Basic information
Public title Non-inferiority study of GM142 compared to Seprafilm in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery
-Multicenter, randomized, single blind, parallel-group comparison study-
Acronym A clinical trial of GM142 in patients with intestinal surgery
Scientific Title Non-inferiority study of GM142 compared to Seprafilm in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery
-Multicenter, randomized, single blind, parallel-group comparison study-
Scientific Title:Acronym A clinical trial of GM142 in patients with intestinal surgery
Region
Japan

Condition
Condition Rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to verify non-inferiority of GM142 compared to Seprafilm on the prevention of adhesion formation in patients with primary rectal cancer scheduled for temporary loop ileostomy during laparoscopic surgery by using GM142 or Seprafilm, and to compare the safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The evaluation of presence/absence of adhesion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 GM142(Adhesion Barrier)
Interventions/Control_2 Seprafilm
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 1. Patients with initial and primary rectal cancer
2. Patients with cStage 0 to cStage III
3. Patients who are scheduled to undergo laparoscopic rectal resection in which a temporary ileostomy is performed.
4. Patients who are scheduled to undergo the closure of ileostomy 8 to 48 weeks after initial surgery.
5. Patients aged 20 years or older at the time of obtaining an informed consent
6. Patients who are fully informed about this study prior to the participation, understand the content, and give a written informed consent of their own free will
Key exclusion criteria Patients who have the following symptoms, surgery, or problems, etc.:
(Preoperative criteria)
1. Scheduled to undergo laparotomy for rectal resection.
2. Having a history of surgery in peritoneal cavity, except operation for appendicitis.
3. cStage IV
4. Scheduled to remove specimens from the site other than the midline incision.
5. Scheduled to undergo ileostomy at umbilical region.
6. ECOG performance status of 3 or greater
7. Peritonitis
8. Subject to emergency operation
9. Gelatin hypersensitivity
10. A history of severe drug allergy
11. Severe diabetes or anomaly of saccharometabolism
12. Significant obesity (BMI of 35 or higher)
13. Requiring chronic treatment with corticosteroids.
14. Scheduled to undergo chemotherapy within 2 weeks after initial surgery.
15. Scheduled to undergo surgery requiring hospital stay during the period from rectal resection to ileostomy closure.
16. Administered unapproved medications or medical devices within 12 weeks prior to obtaining the informed consent.
17. Pregnant or lactating, or wanting to become pregnant during clinical trials.
18. Undergoing dialysis due to hepatic cirrhosis, active hepatitis, or chronic renal failure.
19. Positive for any infection inappropriate for inclusion in the study based on the judgment of the principal investigator or sub-investigators.
20. Gastrointestinal perforations
21. Cancer with no schedule for radical surgery.
22. Psychiatric disease or symptom for which the enrollment in the study is judged unsuitable.
23. Considered less than one year of life expectancy.
24. Any other patients regarded unsuitable by the principal investigator or sub-investigators.
(Perioperative/Discontinuance criteria)
25. Having undergone laparotomy for rectal resection.
26. Having not undergone ileostomy.
27. Having removed specimens from the site other than the midline incision.
28. Having undergone ileostomy at umbilical region.
29. Having not applied either GM142 or Seprafilm.
Target sample size 132

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Kinugasa
Organization Tokyo Medical and Dental University
Division name Graduate School of Medical and Dental Sciences, Systemic Organ Regulation, Gastrointestinal Surgery
Zip code
Address 1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL 03-5803-5252
Email kinugasa.srg1@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Muneaki Ezu
Organization GUNZE LIMITED
Division name Medical Division
Zip code
Address 2-10-4 Nihonbashi,Chuo-ku,Tokyo
TEL 03-3276-8685
Homepage URL
Email GM142-all@gunze.co.jp

Sponsor
Institute GUNZE LIMITED
Institute
Department

Funding Source
Organization GUNZE LIMITED
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
Email

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
2018 Year 10 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 05 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
2018 Year 09 Month 28 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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