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Intra-anal Oxymetazoline in Healthy Adult Volunteers

NCT03529487 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-08-02

No results posted yet for this study

Summary

This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. A total of 32 healthy male and female subjects will be enrolled to receive either Topical Oxymetazoline 1 mg (Cohort A, n=16), 5 mg (Cohort B, n=8) and 10 mg (Cohort C, n=8) applied intra-anally daily (QD) for 11 consecutive days.

Conditions

  • Fecal Incontinence

Interventions

DRUG

Oxymetazoline

Oxymetazoline gel applied intra-analy

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Spaulding Clinical Research LLC

    collaborator OTHER

  • RDD Pharma Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03529487 on ClinicalTrials.gov