JRCT ID: jRCT2080222298
Registered date:19/11/2013
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Post-operative pain after hemorrhoidectomy |
Date of first enrollment | 19/11/2013 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Efficacy and Safety Assessment of efficacy variables : Pain score Assessment of safety parameters : Adverse events |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
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
Primary Sponsor | AMATO PHARMACEUTICAL PRODUCTS, LTD. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-132347 |
Contact
Public contact | |
Name | |
Address | 06-6204-2713 |
Telephone | |
Affiliation | AMATO PHARMACEUTICAL PRODUCTS, LTD. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |