Atopic DermatitisPhase 2NCT00980629
Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
A Phase 2 study testing M516102 in people with Atopic Dermatitis, run by Maruho Co., Ltd. at 4 sites in 4 countries.
Trial summary
This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- M516102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2008to Sep 2010
- 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
- Adult, Older adult
Who may be able to join
- Male or female patients (aged 18-65 years) with a diagnosis of AD.
- Female patients of child bearing potential must be using a medically acceptable form of contraception.
- Patients who are able and willing to give signed informed consent.
- Patients who have pruritus exceed the reference range.
Who cannot join
- Patients who have a history of allergy to hydrocortisone.
- Patients who have a history of relevant drug hypersensitivity.
- Patients who have a history of contact dermatitis induced by a topical steroid.
- Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
- Patients who have a history or presence of any cancer.
- Patients who have any renal or liver insufficiency, or clinically significant cardiac, renal or hepatic disease.
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- Patients who, in the opinion of the investigator, are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
- Patients who have pruritus associated with conditions other than AD.
- Patients who have pruritus only on the face and head.
- Patients who, in the opinion of the investigator, have clinically relevant history or presence of any disease, or surgical history other than AD which is likely to affect the conduct of the study.
- Patients who have used M5161(active ingredient of M516102).
- Patients who cannot communicate reliably with the investigator.
- Patients who are pregnant or lactating.
- Patients who have used any IMP and/or participated in any clinical trial within 3 months.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United Kingdom1 site
The Royal Infirmary of Edinburgh
Edinburgh, EH3 9YW
About this study
Official title: A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
This study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- M516102, placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M516102Drug
Twice a day
placeboDrug
Twice a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startAug 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980629
- Sponsor's protocol ID
- M516102-EU03
- Status last verified
- Nov 2010
- First submitted
- 24 Jul 2009
- Last updated
- 3 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-blind, Parallel Group, Multi-centre Phase II Dose-Finding Study of M516102 in the Treatment of Pruritus Associated With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00980629
- Acronym / sponsor ID
- M516102-EU03
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Study completion
- Sep 2010
- First posted
- 21 Sep 2009 (estimated)
- 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 study is to investigate the efficacy and safety of M516102 and to evaluate the dose response relationship of M516102 and placebo, in the treatment of pruritus associated with atopic dermatitis.
Study design
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients (aged 18-65 years) with a diagnosis of AD.
- Female patients of child bearing potential must be using a medically acceptable form of contraception.
- Patients who are able and willing to give signed informed consent.
- Patients who have pruritus exceed the reference range.
Key exclusion criteria (14 listed)
- Patients who have a history of allergy to hydrocortisone.
- Patients who have a history of relevant drug hypersensitivity.
- Patients who have a history of contact dermatitis induced by a topical steroid.
- Patients who are taking, and who are unwilling not to take, any medications or therapy prohibited by the protocol for the complete duration of the study.
- Patients who have a history or presence of any cancer.
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 |
|---|---|---|
| M516102Twice a day | Drug | – |
| placeboTwice a day | Drug | – |
Primary outcome
Pruritus score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M516102 in people with Atopic Dermatitis, run by Maruho Co., Ltd. at 4 sites in 4 countries.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 3 Nov 2010. 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 France, Germany, Poland, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pruritus score. 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 2010.