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Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days

NCT06593730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-09-19

No results posted yet for this study

Summary

The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.

Conditions

  • Faecal Incontinence

Interventions

DRUG

NRL001 cream 0.5%w/w

DRUG

NRL001 cream 0.75%w/w

DRUG

NRL001 cream 1.0%w/w

DRUG

NRL001 cream 1.5%w/w

DRUG

NRL001 cream 2.0%w/w

DRUG

NRL001 cream 2.5%w/w

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-08-31
Completion
2007-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593730 on ClinicalTrials.gov