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RDD1609 as a Treatment for Idiopathic Pruritus Ani

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ClinicalTrials.gov Identifier: NCT03757403
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
RDD Pharma Ltd

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pruritus Ani Drug: RDD1609 Drug: Mebendazole 100 MG Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: phase 2a randomized double-blinded placebo-controlled cross-over
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: RDD1609 as a Treatment for Idiopathic Pruritus Ani: A Randomized Double Blinded Placebo Controlled Crossover Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
Drug Information available for: Mebendazole

Arm Intervention/treatment
Experimental: RDD1609 followed by Placebo
Application on the perianal area BID
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)
Other Name: Vermox

Experimental: Placebo followed by RDD1609
Application on the perianal area BID
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)
Other Name: Vermox




Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) for itching [ Time Frame: 3 weeks ]
    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".

  2. Pruritus Ani Severity Index score [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures :
  1. Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events) [ Time Frame: 3 weeks ]
    Will be based primarily on the frequency of adverse events and serious adverse events. Other safety data will be summarized as appropriate.


Other Outcome Measures:
  1. Dermatology Life Quality Index [ Time Frame: 3 weeks ]
    Effect of treatment on Dermatology Life Quality Index.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757403


Contacts
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Contact: Nir Barak, MD +972 72 2419062 barak@rddpharma.com
Contact: Robert Shleypak, CCRN +972 72 2419062 robert@rddpharma.com

Locations
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United Kingdom
The Atherstone Surgery Not yet recruiting
Atherstone, United Kingdom, CV9 1EU
Contact: Jeanette Melrose, MD    01827 711568    jeanette.melrose@gp-m84019.nhs.uk   
University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary Not yet recruiting
Bristol, United Kingdom, IG95LP
Contact: Debbie Shipley, MD         
Kings Medical Centre
Buckhurst Hill, United Kingdom, IG95LP
Sheepcot Medical Centre Not yet recruiting
Watford, United Kingdom, WD25 7NL
Contact: Alan Jackson, MD         
Sponsors and Collaborators
RDD Pharma Ltd
Investigators
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Study Chair: Nir Barak, MD RDD Pharma Ltd
Principal Investigator: Jeanette Melrose, MD THE ATHERSTONE SURGERY

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Responsible Party: RDD Pharma Ltd
ClinicalTrials.gov Identifier: NCT03757403     History of Changes
Other Study ID Numbers: RDD123
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anus Diseases
Pruritus
Pruritus Ani
Skin Diseases
Skin Manifestations
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mebendazole
Piperazine
Piperazine citrate
DMP 777
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors