SOOTHER Trial to Treat Rectal Itch
Sponsor
Bell International Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT05288907
Collaborator
(none)
20
1
39.3
0.5
Study Details
Study Description
Brief Summary
Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
SOOTHER Trial: Study of an Over-the-Counter Ointment to Treat Rectal Itch
Actual Study Start Date
:
Sep 1, 2018
Actual Primary Completion Date
:
Aug 13, 2019
Actual Study Completion Date
:
Dec 10, 2021
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Symptom assessment [2 weeks]
SOOTHER Symptom assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst
- Visual ano-rectal exam [2 weeks]
Visual ano-rectal exam assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minnesota Gastroenterology | Plymouth | Minnesota | United States | 55466 |
Sponsors and Collaborators
- Bell International Laboratories
Investigators
- Principal Investigator: Mohammad Saremi, Bell International Laboratories
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bell International Laboratories
ClinicalTrials.gov Identifier:
NCT05288907
Other Study ID Numbers:
- 20181914
First Posted:
Mar 21, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Bell International Laboratories
Additional relevant MeSH terms: