RDD1609 as a Treatment for Idiopathic Pruritus Ani

NCT03757403 | Withdrawn Phase 2

• 1 other identifier: RDD123
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Idiopathic Pruritus Ani

Outcome Measures

Primary Outcomes (2)

• 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".

  3 weeks

• 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.

  3 weeks

Secondary Outcomes (1)

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

  3 weeks

Other Outcomes (1)

• Dermatology Life Quality Index

  3 weeks

Study Arms (2)

RDD1609 followed by Placebo

EXPERIMENTAL

Application on the perianal area BID

Drug: RDD1609; Drug: Mebendazole 100 MG

Placebo followed by RDD1609

EXPERIMENTAL

Application on the perianal area BID

Drug: RDD1609; Drug: Mebendazole 100 MG

Interventions

RDD1609 DRUG

RDD1609 to be applied on the perianal area BID

Placebo followed by RDD1609; RDD1609 followed by Placebo

Mebendazole 100 MG DRUG

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

Also known as: Vermox

Placebo followed by RDD1609; RDD1609 followed by Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• RDD Pharma Ltd: lead

Study Sites (4)

The Atherstone Surgery

Atherstone, CV9 1EU, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary

Bristol, IG95LP, United Kingdom

Location

Kings Medical Centre

Buckhurst Hill, IG95LP, United Kingdom

Location

Sheepcot Medical Centre

Watford, WD25 7NL, United Kingdom

Location

MeSH Terms

Interventions

Mebendazole

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nir Barak, MD

  RDD Pharma Ltd

  STUDY CHAIR

• Jeanette Melrose, MD

  THE ATHERSTONE SURGERY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: phase 2a randomized double-blinded placebo-controlled cross-over

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 28, 2018
• Study Start: May 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

GB (4)