Idiopathic Pruritus AniPhase 2NCT03757403
RDD1609 as a Treatment for Idiopathic Pruritus Ani
A Phase 2 study testing RDD1609 and Mebendazole 100 MG in people with Idiopathic Pruritus Ani, run by RDD Pharma Ltd at 4 sites in United Kingdom.
Trial summary
This is a double-blind, randomized, placebo-controlled, crossover trial, to test the hypothesis that RDD1609 is effective in treating idiopathic pruritus ani. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Pruritus Ani
- What is being tested?
- RDD1609 and Mebendazole 100 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 May 2020to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
The Atherstone Surgery
Atherstone, CV9 1EU
University Hospitals Bristol NHS Foundation Trust- Location Bristol Royal Infirmary
Bristol, IG95LP
Kings Medical Centre
Buckhurst Hill, IG95LP
Sheepcot Medical Centre
Watford, WD25 7NL
About this study
Official title: RDD1609 as a Treatment for Idiopathic Pruritus Ani: A Randomized Double Blinded Placebo Controlled Crossover Study
This is a double-blind, randomized, placebo-controlled, crossover trial, to test the hypothesis that RDD1609 is effective in treating idiopathic pruritus ani.
Read the 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
- Being tested
- RDD1609, Mebendazole 100 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDD1609Drug
RDD1609 to be applied on the perianal area BID
Mebendazole 100 MGDrug
Also called Vermox
Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)
| Study group | Role | What they receive |
|---|---|---|
| RDD1609 followed by Placebo | Experimental | Application on the perianal area BID Receives: Drug: RDD1609; Drug: Mebendazole 100 MG |
| Placebo followed by RDD1609 | Experimental | Application on the perianal area BID Receives: Drug: RDD1609; Drug: Mebendazole 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 3 weeks
Secondary outcomes (1)
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 May 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pruritus AniStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- phase 2a randomized double-blinded placebo-controlled cross-over
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nir Barak, MD, Study chair, RDD Pharma LtdJeanette Melrose, MD, Principal investigator, THE ATHERSTONE SURGERY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757403
- Sponsor's protocol ID
- RDD123
- Status last verified
- Oct 2022
- First submitted
- 25 Nov 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RDD1609 as a Treatment for Idiopathic Pruritus Ani: A Randomized Double Blinded Placebo Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03757403
- Acronym / sponsor ID
- RDD123
- Conditions
- Idiopathic Pruritus Ani
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- phase 2a randomized double-blinded placebo-controlled cross-over
| Arm | Type | Receives |
|---|---|---|
| RDD1609 followed by Placebo | Experimental | Drug: RDD1609, Drug: Mebendazole 100 MGApplication on the perianal area BID |
| Placebo followed by RDD1609 | Experimental | Drug: RDD1609, Drug: Mebendazole 100 MGApplication on the perianal area BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDD1609RDD1609 to be applied on the perianal area BID | Drug | Placebo followed by RDD1609, RDD1609 followed by Placebo |
| Mebendazole 100 MGAlso: VermoxMebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine) | Drug | Placebo followed by RDD1609, RDD1609 followed by Placebo |
Primary outcome
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".
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.
1 secondary outcome
Safety and Tolerability of RDD1609 ( the frequency of adverse events and serious adverse events)
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Barak, MD study chair
RDD Pharma Ltd
Jeanette Melrose, MD principal investigator
THE ATHERSTONE SURGERY
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDD1609 and Mebendazole 100 MG in people with Idiopathic Pruritus Ani, run by RDD Pharma Ltd at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) for itching (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.