Clinical trial NCT03757403: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Idiopathic Pruritus Ani
Lead sponsor: RDD Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: phase 2a randomized double-blinded placebo-controlled cross-over
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) for itching
timeFrame: 3 weeks
measure: Pruritus Ani Severity Index score
timeFrame: 3 weeks
Secondary outcomes:
measure: Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)
timeFrame: 3 weeks
Other outcomes:
measure: Dermatology Life Quality Index
timeFrame: 3 weeks
Locations:
city: Atherstone
country: United Kingdom
facility: The Atherstone Surgery
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary
city: Buckhurst Hill
country: United Kingdom
facility: Kings Medical Centre
city: Watford
country: United Kingdom
facility: Sheepcot Medical Centre
Study officials:
affiliation: RDD Pharma Ltd
name: Nir Barak, MD
role: STUDY_CHAIR
affiliation: THE ATHERSTONE SURGERY
name: Jeanette Melrose, MD
role: PRINCIPAL_INVESTIGATOR
References: