NCT03757403

RDD1609 as a Treatment for Idiopathic Pruritus Ani

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: RDD Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	RDD1609	RDD1609 to be applied on the perianal area BID
DRUG	Mebendazole 100 MG	Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-11-30
• Completion: 2020-12-31
• First posted: 2018-11-28
• Last updated: 2022-11-03

Locations

4 sites across 1 country: United Kingdom