Trial · NCT01170949
Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
NCT01170949, Phase 2, Terminated, Marcus Maurer; results first posted 2016-12-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria. Trials, record NCT01170949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01170949
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
- NCT number
- NCT01170949
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Marcus Maurer
- Conditions
- Chronic Urticaria
- Interventions
- Miltefosine, Placebo
- First posted
- 2010-07-28
- Last updated
- 2016-12-26
- Other registries' IDs
- eudract:2007-007657-31
- Results first posted
- 2016-12-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urticaria Activity Score (% Change From Baseline) | Day 28 | The weekly UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories "number of wheals" and "intensity of pruritus". "Number of wheals" is scored as 0 = no wheals, 1 = some wheals (\<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. "Intensity of pruritus" is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urticaria Activity Score (% Change From Baseline) | Day 28 | ITT = 73 | percentage of UAS baseline | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urticaria Activity Score (% Change From Baseline) | Miltefosine | -25.5 | Standard Deviation 38.2 | percentage of UAS baseline | |
| Urticaria Activity Score (% Change From Baseline) | Placebo | -10.1 | Standard Deviation 33.4 | percentage of UAS baseline |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Miltefosine | 50 | |
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | COMPLETED | Miltefosine | 43 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Miltefosine | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Miltefosine | 35 | 50 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 13 | 26 | |
| other | Nausea | Gastrointestinal disorders | Miltefosine | 14 | 50 | 28 |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 26 | |
| other | Vomiting | Gastrointestinal disorders | Miltefosine | 10 | 50 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 26 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Miltefosine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Miltefosine | 44 | 50 |
| Total, other adverse events | Placebo | 17 | 26 |
| Total, serious adverse events | Miltefosine | 0 | 50 |
| Total, serious adverse events | Placebo | 0 | 26 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Miltefosine vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01170949
GET https://conductscience.org/api/trials/v1/NCT01170949/registered