A Phase 2 interventional study of RDD1609 and Mebendazole 100 MG in Idiopathic Pruritus Ani, sponsored by RDD Pharma Ltd. Withdrawn at 4 sites in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by RDD Pharma Ltd · Phase 2, Interventional, and Treatment
This is a double-blind, randomized, placebo-controlled, crossover trial, to test the hypothesis that RDD1609 is effective in treating idiopathic pruritus ani.
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.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
Browse Pruritus studies →RDD Pharma Ltd is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application on the perianal area BID
Drug: RDD1609 · Drug: Mebendazole 100 MG
Application on the perianal area BID
Drug: RDD1609 · Drug: Mebendazole 100 MG
RDD1609 to be applied on the perianal area BID
Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)
Also known as: Vermox
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".
Time frame: 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.
Time frame: 3 weeks
Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)
Will be based primarily on the frequency of adverse events and serious adverse events. Other safety data will be summarized as appropriate.
Time frame: 3 weeks
Dermatology Life Quality Index
Effect of treatment on Dermatology Life Quality Index.
Time frame: 3 weeks
This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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RDD Pharma Ltd