NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080222298

Registered date:19/11/2013

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedPost-operative pain after hemorrhoidectomy
Date of first enrollment19/11/2013
Target sample size
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : AM-4 ointment INN of investigational material : Oxetacaine Therapeutic category code : 121 Local anesthetics Dosage and Administration for Investigational material : Topical application

Outcome(s)

Primary OutcomeEfficacy and Safety Assessment of efficacy variables : Pain score Assessment of safety parameters : Adverse events
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria-Patients undergoing hemorrhoidectomy of hemorrhoids by ligation and excision -Patients whose ASA (American Society of Anesthesiologists) is 1 or 2
Exclude criteria-Patients with other serious complications -Patients with other anorectal diseases -Patients with previous or present allergic diseases and drug allergy -Patients who are pregnant, breast-feeding, and suspected pregnancy

Related Information

Contact

Public contact
Name
Address 06-6204-2713
Telephone
E-mail
Affiliation AMATO PHARMACEUTICAL PRODUCTS, LTD.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation