Trial · NCT00866788
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | The UAS is a composite diary-recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42. |
| Secondary | Change in the Weekly Pruritus Score From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21. |
| Secondary | Change in the Weekly Score for Number of Hives From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21. |
| Secondary | Change in the Weekly Score for Sleep Interference From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | The extent to which hives or itch interfered with participants' sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21. |
| Secondary | Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4 | Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27) | Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21. |
| Secondary | Number of Patients With Adverse Events by Severity | 16 weeks overall (data reported separately for "up to 4 weeks" and "Weeks 5 to 16") | The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities. Additional AE data is provided in the AE section below. The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of an AE. A "Serious" AE is defined below. |
| Secondary | Number of Participants With Immunogenicity | 16 weeks | Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Maximum Observed Concentration (Cmax) of Omalizumab | Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) | Cmax is the maximum (or peak) concentration of omalizumab in serum. |
| Secondary | Time to Maximum Concentration (Tmax) of Omalizumab | Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) | Tmax is the time to maximum concentration of omalizumab. |
| Secondary | Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf) | Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) | AUCinf is the area under the concentration-time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg\*day/mL). Only participants having complete profiles and completed the study were included in the analysis. |
| Secondary | Terminal Half-Life (t1/2) of Omalizumab | Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16) | Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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