Cold Contact UrticariaPhase 2PAFCUTIIINCT01605487
Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria
A Phase 2 study testing Rupatadine in people with Cold Contact Urticaria, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany) will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold Contact Urticaria
- What is being tested?
- Rupatadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Oct 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed and dated
- Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
- Outpatients with CCU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch after contact cooling of the skin. Provocation should be performed by application of Temptest®3.0 which allows for reproducible and standardized cold provocation tests and the identification of temperature and stimulation time thresholds.
- Age 18 and above 18 years.
- No participation in other clinical trials 1 months before and after participation in this study
Who cannot join
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).
- The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
- The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
- ECG alterations of repolarisation (QTc prolongations > 450ms)
Show all 19Show fewer
- Blood pressure >180/100 mmHg and/or heart rate >100/min.
- Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value)
- History of hypersensitivity or allergic reaction to rupatadine or its ingredients or any other antihistamine compounds.
- Presence of active cancer which requires chemotherapy or radiation therapy
- Presence of lactose and galactose intolerance or with glucose-galactose malabsorption
- Simultaneous chronic spontaneous or physical urticaria that could interfere CCU clinical assessment
- Intake of antihistamines or antileukotrienes within 7 days before beginning of the study
- Intake of oral or depot corticosteroids within 14 days prior to screening visit
- Use of systemic immunosupressants/immunomodulators like cyclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
- Use of ketoconazole, erythromycin or potential inhibitors of the isoenzyme CYP3A4 of the cytochrome P450.
- Currently abusing drugs or alcohol
- Unwilling or unable to comply with the protocol
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology and Allergy
Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin
About this study
Official title: Double-blind, Three-way Cross-over, Placebo-controlled Study to Assess the Efficacy, Safety and Mechanisms of Treatment With Rupatadine 20 mg and 40 mg in Cold Contact Urticaria (CCU)
Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany) will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C simultaneously in a standardized and reproducible way and thus the determination of individual temperature and/or stimulation time thresholds.
In addition mediators related from activated must cells such as histamine, PAF, PGD2 should be identified in the period between the application of stimulus and the appearance of symptoms of cold urticaria and should be characterized qualitatively and quantitatively.
- Conditions
- Cold Contact Urticaria
- Being tested
- Rupatadine
- Medical subject headings
- Cold Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RupatadineDrug
Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days
RupatadineDrug
Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days
RupatadineDrug
Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days
RupatadineDrug
Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days
RupatadineDrug
Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days
RupatadineDrug
Rupatadine in Tab. 10mg: 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Rupatadine 20mg - Placebo - Rupatadine 40mg | Other | Not described Receives: Drug: Rupatadine |
| Rupatadine 20mg - Rupatadine 40mg - Placebo | Other | Not described Receives: Drug: Rupatadine |
| Placebo - Rupatadine 20mg - Rupatadine 40mg | Other | Not described Receives: Drug: Rupatadine |
| Rupatadine 40mg - Placebo - Rupatadine 20mg | Other | Not described Receives: Drug: Rupatadine |
| Placebo - Rupatadine 40mg - Rupatadine 20mg | Other | Not described Receives: Drug: Rupatadine |
| Rupatadine 40mg - Rupatadine 20mg - Placebo | Other | Not described Receives: Drug: Rupatadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical stimulation time threshold(CSTT) after challenge with cold
Critical stimulation time threshold (CSTT) determines the shortest stimulation time sufficient for inducing a wheal-and-flare reaction
Measured: Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Critical temperature threshold (CTT)after challenge with cold
Critical temperature threshold (CTT) determines the highest temperature sufficient for inducing a wheal-and-flare reaction
Measured: Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Secondary outcomes (2)
Mast cell mediator release
Measured: Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria
Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital sings and adverse event reporting
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold Contact UrticariaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar
- Responsible party
- Principal investigator, Marina Abajian, Charite University, Berlin, Germany
- Investigators
- Karoline Krause, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605487
- Sponsor's protocol ID
- PAFCUTIII
- Acronym
- PAFCUTIII
- Status last verified
- Apr 2014
- First submitted
- 11 May 2012
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Three-way Cross-over, Placebo-controlled Study to Assess the Efficacy, Safety and Mechanisms of Treatment With Rupatadine 20 mg and 40 mg in Cold Contact Urticaria (CCU)
- ClinicalTrials.gov ID
- NCT01605487
- Acronym / sponsor ID
- PAFCUTIII / PAFCUTIII
- Conditions
- Cold Contact Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Hospital del Mar
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 May 2012 (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.
Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany) will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C simultaneously in a standardized and reproducible way and thus the determination of individual temperature and/or stimulation time thresholds.
In addition mediators related from activated must cells such as histamine, PAF, PGD2 should be identified in the period between the application of stimulus and the appearance of symptoms of cold urticaria and should be characterized qualitatively and quantitatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Rupatadine 20mg - Placebo - Rupatadine 40mg | Other | Drug: Rupatadine |
| Rupatadine 20mg - Rupatadine 40mg - Placebo | Other | Drug: Rupatadine |
| Placebo - Rupatadine 20mg - Rupatadine 40mg | Other | Drug: Rupatadine |
| Rupatadine 40mg - Placebo - Rupatadine 20mg | Other | Drug: Rupatadine |
| Placebo - Rupatadine 40mg - Rupatadine 20mg | Other | Drug: Rupatadine |
| Rupatadine 40mg - Rupatadine 20mg - Placebo | Other | Drug: Rupatadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed and dated
- Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
- Outpatients with CCU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch after contact cooling of the skin. Provocation should be performed by application of Temptest®3.0 which allows for reproducible and standardized cold provocation tests and the identification of temperature and stimulation time thresholds.
- Age 18 and above 18 years.
- No participation in other clinical trials 1 months before and after participation in this study
Key exclusion criteria (19 listed)
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).
- The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
- The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
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 |
|---|---|---|
| RupatadineRupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days | Drug | Rupatadine 20mg - Placebo - Rupatadine 40mg |
| RupatadineRupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days | Drug | Rupatadine 20mg - Rupatadine 40mg - Placebo |
| RupatadinePlacebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days | Drug | Placebo - Rupatadine 20mg - Rupatadine 40mg |
| RupatadineRupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days | Drug | Rupatadine 40mg - Placebo - Rupatadine 20mg |
| RupatadinePlacebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days | Drug | Placebo - Rupatadine 40mg - Rupatadine 20mg |
| RupatadineRupatadine in Tab. 10mg: 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days | Drug | Rupatadine 40mg - Rupatadine 20mg - Placebo |
Primary outcome
Critical stimulation time threshold(CSTT) after challenge with cold
Time frame: Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Critical stimulation time threshold (CSTT) determines the shortest stimulation time sufficient for inducing a wheal-and-flare reaction
Critical temperature threshold (CTT)after challenge with cold
Time frame: Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Critical temperature threshold (CTT) determines the highest temperature sufficient for inducing a wheal-and-flare reaction
2 secondary outcomes
Mast cell mediator release
Time frame: Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria
Time frame: up to 9 weeks
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 15 Oct 2014.
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A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
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Active, not recruitingPhase 3
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
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RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
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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.
Karoline Krause, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rupatadine in people with Cold Contact Urticaria, run by Charite University, Berlin, Germany at 1 site in Germany.
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 5 inclusion and 19 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 15 Oct 2014. 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 Germany. 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?
Critical stimulation time threshold(CSTT) after challenge with cold (time frame: Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)). 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 15 Oct 2014.