UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose antispasmodic agents administration at the cecum in the colon increase adenoma detection rates by colonoscopy ? : a randomized double-blind placebo-controlled trial
Title of the study (Brief title)	The effect of antispasmodic agents for the adenoma detection by colonosocpy
Region	Japan

Condition
Condition	Colonic adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of antispasmodic agents administration at the cecum in the colon increase adenoma detection rate by colonoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Adenoma detection rate of the colon
Key secondary outcomes	Side effects of antispasmodic agents

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Antispasmodic agents administration
Interventions/Control_2	Normal saline 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Inpatients and outpatients of Sentohiru hospital who have the positive of fecal occult blood test or clinical symptoms (Ex: hematochesia, abdominal pain, constipation). 2) Inpatients and outpatients of Sentohiru hospital who are scheduled to examine the colon for polyp surveillance.
Key exclusion criteria	1.Patients with ileus. 2.Pregnant and lactating patients. 3.Patients after the colectomy. 4.Patients with colon cancer. 5.Patients with inflammatory bowel disease 6.Patients with FAP or HNPCC 7.Patients who judged inappropriate for clinical trial for severe comorbidity. 8.Patients with DM and Ischemic heart disease or BPH or Glaucoma.
Target sample size	200

Research contact person
Name of lead principal investigator	Shingo Higaki
Organization	Sentohiru Hospital
Division name	Depertment of Gastroenterology
Address	3-7-18 Imamurakita,Ube,Yamaguchi
TEL	0836-51-5111
Email	shigaki@sthill-hp.or.jp

Public contact
Name of contact person	Mineko Nagasaki
Organization	Sentohiru Hospital
Division name	Respiratory division
Address	3-7-18 Imamurakita,Ube,Yamaguchi
TEL	0836-51-5111
Homepage URL
Email	nishikiwa@sthill-hp.or.jp

Sponsor
Institute	Sentohiru Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Sentohiru Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 28 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry	2016 Year 03 Month 01 Day
Date trial data considered complete	2016 Year 03 Month 01 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 01 Day
Last modified on	2016 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020987