Trial · NCT01271075
Bilastine Updosing - Characterization of Underlying Mechanisms
NCT01271075, Phase 2, Phase 3, Completed, Charite University, Berlin, Germany
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bilastine Updosing - Characterization of Underlying Mechanisms. Trials, record NCT01271075. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01271075
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bilastine Updosing - Characterization of Underlying Mechanisms
- NCT number
- NCT01271075
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Charite University, Berlin, Germany
- Conditions
- Cold Contact Urticaria
- Interventions
- Bilastine, Bilastine
- First posted
- 2011-01-06
- Last updated
- 2012-05-31
- Other registries' IDs
- eudract:2010-019344-39
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The effects of a standard dose (20 mg) and higher than standard doses of bilastine (40 mg and 80 mg) on symptom development in CCU patients | 6 visits in 12-14 weeks | Change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20 mg, 40 mg, 80 mg). |
| Secondary | The effects of a standard dose (20 mg) and higher than standard doses of bilastine (80 mg) on mast cell mediator release in CCU patients | Visit 2 (day 0), visit 3 (day 7) and visit 6 (day 70) | Change in mast cell mediator release, including histamine and mast cell-derived cytokines (e.g. IL-1, IL-6, IL-8, IL-13, TNF) after standard dose treatment with bilastine (20 mg) compared to high dose bilastine (80 mg) and baseline. |
| Secondary | Safety and tolerability following administration of bilastine to patients with cold contact urticaria | up to 14 weeks | Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01271075
GET https://conductscience.org/api/trials/v1/NCT01271075/registered