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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and safety of AM-4 ointment for Post-Operative pain in Patients after Hemorrhoidectomy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and safety of AM-4 ointment for Post-Operative pain in Patients after Hemorrhoidectomy

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222298
Enrollment
Unknown
Registered
2013-11-19
Start date
2013-11-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative pain after hemorrhoidectomy

Interventions

investigational material(s) Generic name etc : AM-4 ointment INN of investigational material : Oxetacaine Therapeutic category code : 121 Local anesthetics Dosage and Administration for Investigationa

Sponsors

AMATO PHARMACEUTICAL PRODUCTS, LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients undergoing hemorrhoidectomy of hemorrhoids by ligation and excision -Patients whose ASA (American Society of Anesthesiologists) is 1 or 2

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Efficacy and Safety Assessment of efficacy variables : Pain score Assessment of safety parameters : Adverse events—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026