PruritusPhase 4NCT00261079
Fexofenadine in Pruritic Skin Disease
A Phase 4 study testing Fexofenadine in people with Pruritus, run by Handok Inc. at 1 site in South Korea.
Trial summary
Primary objective: To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: To evaluate patient's satisfaction of Allegra treatment Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Pruritus
- What is being tested?
- Fexofenadine
- How many people
- 435 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2005to Oct 2006
- Phase
- Phase 4
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients diagnosed with atopic dermatitis, contact dermatitis
Who cannot join
- Other skin disease except atopic dermatitis, contact dermatitis.
- Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day.
- Pruritus localized only head and face
- Subjects with severe hepatic, renal, heart dysfunction.
- Subjects with history of alcohol and drug abuse.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
Primary objective:
- To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease
Secondary objective:
- To evaluate patient's satisfaction of Allegra treatment
- Conditions
- Pruritus
- Being tested
- Fexofenadine
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FexofenadineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of physician's assessment on pruritic score before and after 7-day treatment.
Secondary outcomes (1)
Patient visual analogue scale change and Overall satisfaction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startApr 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hyou-Young Rhim, MD, Study director, Handok Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261079
- Sponsor's protocol ID
- M016455_4125
- Status last verified
- Nov 2007
- First submitted
- 1 Dec 2005
- Last updated
- 7 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
- ClinicalTrials.gov ID
- NCT00261079
- Acronym / sponsor ID
- M016455_4125
- Conditions
- Pruritus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 2 Dec 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.
Primary objective:
- To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease
Secondary objective:
- To evaluate patient's satisfaction of Allegra treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients diagnosed with atopic dermatitis, contact dermatitis
Key exclusion criteria (6 listed)
- Other skin disease except atopic dermatitis, contact dermatitis.
- Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day.
- Pruritus localized only head and face
- Subjects with severe hepatic, renal, heart dysfunction.
- Subjects with history of alcohol and drug abuse.
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 |
|---|---|---|
| Fexofenadine | Drug | – |
Primary outcome
The change of physician's assessment on pruritic score before and after 7-day treatment.
1 secondary outcome
Patient visual analogue scale change and Overall satisfaction.
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 7 Nov 2007.
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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.
Hyou-Young Rhim, MD study director
Handok Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fexofenadine in people with Pruritus, run by Handok Inc. at 1 site in South Korea.
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 6 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 7 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The change of physician's assessment on pruritic score before and after 7-day treatment.. 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 7 Nov 2007.