Dermatitis, Allergic ContactPhase 1NCT00141180
CP-481,715 Nickel Allergy Study.
A Phase 1 study testing CP-481,715 in people with Dermatitis, Allergic Contact, run by Pfizer at 5 sites in 2 countries.
Trial summary
To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Allergic Contact
- What is being tested?
- CP-481,715
- How many people
- 48 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Sep 2003to Oct 2005
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A history of nickel allergy confirmed by a visual positive reaction (graded at least ++) to T.R.U.E. TEST.
Who cannot join
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding contact allergic dermatitis or untreated, asymptomatic, seasonal allergies at time of dosing).
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0314
Pfizer Investigational Site
Austin, Texas, 78759
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
New York, New York, 10032
About this study
Official title: Placebo-Controlled, Randomized, Parallel Group, Multiple-Dose Study to Evaluate the Effects of CP-481,715 on Clinical Response and Cellular Infiltration Following Contact Allergen Challenge to the Skin of Nickel Allergic Subjects.
To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist.
- Conditions
- Dermatitis, Allergic Contact
- Being tested
- CP-481,715
- Medical subject headings
- Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-481,715Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of CP-481,715 on clinical response and cell infiltration after nickel challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startSep 2003
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, Allergic ContactStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141180
- Sponsor's protocol ID
- A3081018
- Status last verified
- Nov 2005
- First submitted
- 30 Aug 2005
- Last updated
- 25 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Randomized, Parallel Group, Multiple-Dose Study to Evaluate the Effects of CP-481,715 on Clinical Response and Cellular Infiltration Following Contact Allergen Challenge to the Skin of Nickel Allergic Subjects.
- ClinicalTrials.gov ID
- NCT00141180
- Acronym / sponsor ID
- A3081018
- Conditions
- Dermatitis, Allergic Contact
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Oct 2005
- First posted
- 1 Sep 2005 (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.
To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- A history of nickel allergy confirmed by a visual positive reaction (graded at least ++) to T.R.U.E. TEST.
Key exclusion criteria (1 listed)
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding contact allergic dermatitis or untreated, asymptomatic, seasonal allergies at time of dosing).
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 |
|---|---|---|
| CP-481,715 | Drug | – |
Primary outcome
Effect of CP-481,715 on clinical response and cell infiltration after nickel challenge
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 25 Jul 2006.
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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.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CP-481,715 in people with Dermatitis, Allergic Contact, run by Pfizer at 5 sites in 2 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 1 inclusion and 1 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 25 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Effect of CP-481,715 on clinical response and cell infiltration after nickel challenge. 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 25 Jul 2006.