SOOTHER Trial to Treat Rectal Itch

July 20, 2022 updated by: Bell International Laboratories

SOOTHER Trial: Study of an Over-the-Counter Ointment to Treat Rectal Itch

Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Plymouth, Minnesota, United States, 55466
        • Minnesota Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with pruritus ani (anal itch/discomfort)

Description

Inclusion Criteria:

  • Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam.

Exclusion Criteria:

  • Inability to understand informed consent, history of inflammatory bowel disease, known venereal disease, or immunodeficiency disease, history of or current anal or perianal abscess, anal or rectal surgery within the past 12 weeks, pregnancy or breastfeeding female, or signs of other rectal diseases such as anorectal fistula, infection, perianal eczema or tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pruritus ani patients
Adult patients with pruritus ani (rectal itch) treated with lidocaine ointment
Drug: Lidocaine Ointment
Composite over-the-counter lidocaine ointment administered twice daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom assessment
Time Frame: 2 weeks
SOOTHER Symptom assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst
2 weeks
Visual ano-rectal exam
Time Frame: 2 weeks
Visual ano-rectal exam assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bell International Laboratories

Investigators

  • Principal Investigator: Mohammad Saremi, Bell International Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

August 13, 2019

Study Completion (Actual)

December 10, 2021

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20181914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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