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RDD1609 as a Treatment for Idiopathic Pruritus Ani

Primary Purpose

Idiopathic Pruritus Ani

Status

Withdrawn

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

RDD1609

Mebendazole 100 MG

About this trial

This is an interventional treatment trial for Idiopathic Pruritus Ani

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
Male and female patients, age 18 - 65 years with idiopathic PA.
Screening VAS for itching of 60 mm and above.
Female subjects of child-bearing potential must have a negative urine pregnancy test. Females of childbearing potential must practice a highly effective method of pregnancy prevention (defined as <1% pregnancies per 100 women per year) from one month before screening to one month after the follow-up visit, such as: surgical sterilization, hormonal implant, intrauterine device, or male condom + female diaphragm + vaginal spermicide. Female subject with any of the following circumstances is not required to use a highly effective method of pregnancy prevention: status post-hysterectomy; or, status post-tubal ligation; or, post-menopausal state (defined as >= 12 months of spontaneous amenorrhea) or < 12 months of spontaneous amenorrhea with a blood follicle stimulating hormone > 40 MIU/ml.
Subject has normal (or abnormal and clinically insignificant) laboratory values at Screening.
Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures.
Subject has not used and agrees to abstain from taking any prescription or non-prescription medications, cosmetics, including herbal and dietary supplements (such as St. John's wort) within 7 days prior to the first dose of study medication (unless authorized by the Investigator and Medical Monitor).

Exclusion Criteria:

Known hypersensitivity to RDD1609.
Known hypersensitivity to Mebendazole.
Previously treated with methylene blue for pruritus ani.
Randomization VAS for itching that is <25 mm than the screening VAS.
Anorectal conditions such as malignant tumors of the anus and rectum, inflammatory bowel disease, fistulain- ano, fissure-in-ano, incontinence, condylomata, and second- and third-degree hemorrhoids and any other anorectal conditions that requires medicinal treatment.
Patients who had previous major proctological surgery.
Generalized skin disorders.
Active psychiatric disorders.
Diabetes mellitus all types.
Known to be HIV positive.
Current or within the last 4 weeks steroid or pregabalin or gabapentin or antihistamine systemic or local treatment.

Sites / Locations

The Atherstone Surgery
University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary
Kings Medical Centre
Sheepcot Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

RDD1609 followed by Placebo

Placebo followed by RDD1609

Arm Description

Application on the perianal area BID

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS) for itching

Change in severity of itch, measured using Visual Analogue Scale score for itching from baseline through the end of treatment. The Visual Analogue Scale is a 10-cm long line (oriented horizontally), on which patients indicate the severity of their itching by crossing the line at the point that corresponded to their itching severity. The left end of the line indicates "no itch" and right end of the line indicates "worth itch ever".

Pruritus Ani Severity Index score

Effect of RDD1609 on the Pruritus Ani Severity Index score (Mild, Moderate, Severe, Chronic), which is a grading system used to describe severity of physical findings in patients with pruritus ani.

Secondary Outcome Measures

Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)

Will be based primarily on the frequency of adverse events and serious adverse events. Other safety data will be summarized as appropriate.

Full Information

NCT ID

NCT03757403

First Posted

November 25, 2018

Last Updated

October 31, 2022

Sponsor

RDD Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03757403

Brief Title

RDD1609 as a Treatment for Idiopathic Pruritus Ani

Official Title

RDD1609 as a Treatment for Idiopathic Pruritus Ani: A Randomized Double Blinded Placebo Controlled Crossover Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Covid-19

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RDD Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a double-blind, randomized, placebo-controlled, crossover trial, to test the hypothesis that RDD1609 is effective in treating idiopathic pruritus ani.

Detailed Description

This is a phase 2a randomized double-blinded placebo-controlled cross-over design study in patients with idiopathic pruritus ani. 24 patients, male and females, aged 18 -65 with severe idiopathic pruritus ani (VAS score above 60), will be randomized to this study. Patients that meet all inclusion criteria and do not have exclusion criteria at randomization visit will be randomly assigned to one of the two treatment groups: Group 1 will receive 3 weeks of RDD1609 for 3 weeks, followed by 3 weeks of treatment with placebo. Group 2 will receive 3 weeks of treatment with placebo followed by 3 weeks of treatment with RDD1609.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pruritus Ani

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

phase 2a randomized double-blinded placebo-controlled cross-over

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RDD1609 followed by Placebo

Arm Type

Experimental

Arm Description

Application on the perianal area BID

Arm Title

Placebo followed by RDD1609

Arm Type

Experimental

Arm Description

Application on the perianal area BID

Intervention Type

Drug

Intervention Name(s)

RDD1609

Intervention Description

RDD1609 to be applied on the perianal area BID

Intervention Type

Drug

Intervention Name(s)

Mebendazole 100 MG

Other Intervention Name(s)

Vermox

Intervention Description

Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)

Primary Outcome Measure Information:

Title

Visual Analogue Scale (VAS) for itching

Description

Time Frame

3 weeks

Title

Pruritus Ani Severity Index score

Description

Effect of RDD1609 on the Pruritus Ani Severity Index score (Mild, Moderate, Severe, Chronic), which is a grading system used to describe severity of physical findings in patients with pruritus ani.

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)

Description

Will be based primarily on the frequency of adverse events and serious adverse events. Other safety data will be summarized as appropriate.

Time Frame

3 weeks

Other Pre-specified Outcome Measures:

Title

Dermatology Life Quality Index

Description

Effect of treatment on Dermatology Life Quality Index.

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. Male and female patients, age 18 - 65 years with idiopathic PA. Screening VAS for itching of 60 mm and above. Female subjects of child-bearing potential must have a negative urine pregnancy test. Females of childbearing potential must practice a highly effective method of pregnancy prevention (defined as <1% pregnancies per 100 women per year) from one month before screening to one month after the follow-up visit, such as: surgical sterilization, hormonal implant, intrauterine device, or male condom + female diaphragm + vaginal spermicide. Female subject with any of the following circumstances is not required to use a highly effective method of pregnancy prevention: status post-hysterectomy; or, status post-tubal ligation; or, post-menopausal state (defined as >= 12 months of spontaneous amenorrhea) or < 12 months of spontaneous amenorrhea with a blood follicle stimulating hormone > 40 MIU/ml. Subject has normal (or abnormal and clinically insignificant) laboratory values at Screening. Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures. Subject has not used and agrees to abstain from taking any prescription or non-prescription medications, cosmetics, including herbal and dietary supplements (such as St. John's wort) within 7 days prior to the first dose of study medication (unless authorized by the Investigator and Medical Monitor). Exclusion Criteria: Known hypersensitivity to RDD1609. Known hypersensitivity to Mebendazole. Previously treated with methylene blue for pruritus ani. Randomization VAS for itching that is <25 mm than the screening VAS. Anorectal conditions such as malignant tumors of the anus and rectum, inflammatory bowel disease, fistulain- ano, fissure-in-ano, incontinence, condylomata, and second- and third-degree hemorrhoids and any other anorectal conditions that requires medicinal treatment. Patients who had previous major proctological surgery. Generalized skin disorders. Active psychiatric disorders. Diabetes mellitus all types. Known to be HIV positive. Current or within the last 4 weeks steroid or pregabalin or gabapentin or antihistamine systemic or local treatment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nir Barak, MD

Organizational Affiliation

RDD Pharma Ltd

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jeanette Melrose, MD

Organizational Affiliation

THE ATHERSTONE SURGERY

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Atherstone Surgery

City

Atherstone

ZIP/Postal Code

CV9 1EU

Country

United Kingdom

Facility Name

University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary

City

Bristol

ZIP/Postal Code

IG95LP

Country

United Kingdom

Facility Name

Kings Medical Centre

City

Buckhurst Hill

ZIP/Postal Code

IG95LP

Country

United Kingdom

Facility Name

Sheepcot Medical Centre

City

Watford

ZIP/Postal Code

WD25 7NL

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

RDD1609 as a Treatment for Idiopathic Pruritus Ani

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