Status:
WITHDRAWN
RDD1609 as a Treatment for Idiopathic Pruritus Ani
Lead Sponsor:
RDD Pharma Ltd
Conditions:
Idiopathic Pruritus Ani
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 prur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03757403
Start Date
May 1 2020
End Date
December 31 2020
Last Update
November 3 2022
Active Locations (4)
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1
The Atherstone Surgery
Atherstone, United Kingdom, CV9 1EU
2
University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary
Bristol, United Kingdom, IG95LP
3
Kings Medical Centre
Buckhurst Hill, United Kingdom, IG95LP
4
Sheepcot Medical Centre
Watford, United Kingdom, WD25 7NL