RDD1609 as a Treatment for Idiopathic Pruritus Ani

NCT ID: NCT03757403

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-12-31

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.

Conditions

Idiopathic Pruritus Ani

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RDD1609 followed by Placebo

Application on the perianal area BID

Group Type: EXPERIMENTAL

RDD1609

Intervention Type: DRUG

RDD1609 to be applied on the perianal area BID

Mebendazole 100 MG

Intervention Type: DRUG

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

Placebo followed by RDD1609

Application on the perianal area BID

Group Type: EXPERIMENTAL

RDD1609

Intervention Type: DRUG

RDD1609 to be applied on the perianal area BID

Mebendazole 100 MG

Intervention Type: DRUG

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

Interventions

RDD1609

RDD1609 to be applied on the perianal area BID

Intervention Type: DRUG

Mebendazole 100 MG

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

Intervention Type: DRUG

Other Intervention Names

Vermox

Eligibility Criteria

Inclusion Criteria

1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.

2. Male and female patients, age 18 - 65 years with idiopathic PA.

3. Screening VAS for itching of 60 mm and above.

4. 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.

5. Subject has normal (or abnormal and clinically insignificant) laboratory values at Screening.

6. Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures.

7. 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

1. Known hypersensitivity to RDD1609.

2. Known hypersensitivity to Mebendazole.

3. Previously treated with methylene blue for pruritus ani.

4. Randomization VAS for itching that is <25 mm than the screening VAS.

5. 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.

6. Patients who had previous major proctological surgery.

7. Generalized skin disorders.

8. Active psychiatric disorders.

9. Diabetes mellitus all types.

10. Known to be HIV positive.

11. Current or within the last 4 weeks steroid or pregabalin or gabapentin or antihistamine systemic or local treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RDD Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nir Barak, MD

Role: STUDY_CHAIR

RDD Pharma Ltd

Jeanette Melrose, MD

Role: PRINCIPAL_INVESTIGATOR

THE ATHERSTONE SURGERY

Locations

The Atherstone Surgery

Atherstone, , United Kingdom

University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary

Bristol, , United Kingdom

Kings Medical Centre

Buckhurst Hill, , United Kingdom

Sheepcot Medical Centre

Watford, , United Kingdom

Countries

United Kingdom

Other Identifiers

RDD123

Identifier Type: -

Identifier Source: org_study_id