Trial · NCT00471705
Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
NCT00471705, Phase 3, Completed, Universidad de Antioquia; results first posted 2010-07-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia. Trials, record NCT00471705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00471705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
- NCT number
- NCT00471705
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 437 participants, actual
- Lead sponsor
- Universidad de Antioquia
- Conditions
- Cutaneous Leishmaniasis
- Interventions
- Miltefosine, Thermotherapy, Glucantime®
- First posted
- 2007-05-10
- Last updated
- 2019-01-16
- Results first posted
- 2010-07-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Clinical Response | Until 6 months posttreatment | Complete Clinical response: Initial cure plus the absence of recurrences or mucosal lesions for 6 months after the end of treatment. Note: nitial cure: Complete re-epithelialization of all ulcers and complete disappearance of the induration up to 3 months after the end of treatment. |
| Primary | Failure | Until 3 months posttreatment | At least 50% increase in lesion size at the end of treatment, absence of clinical response at 6 weeks, or any sign of lesion activity 3 months after the end of treatment |
| Secondary | Recurrence | Until 6 months post-treatment | Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Clinical Response | Until 6 months posttreatment | The efficacy of the treatments was calculated by intention to treat and by protocol. | participants | NUMBER |
| SECONDARY | Recurrence | Until 6 months post-treatment | Participants | NUMBER | |
| PRIMARY | Failure | Until 3 months posttreatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Clinical Response | Miltefosine | 85 | participants | ||
| Complete Clinical Response | Glucantime® | 103 | participants | ||
| Complete Clinical Response | Thermotherapy | 86 | participants | ||
| Recurrence | Miltefosine | 3 | Participants | ||
| Recurrence | Glucantime® | 4 | Participants | ||
| Recurrence | Thermotherapy | 6 | Participants | ||
| Failure | Miltefosine | 34 | participants | ||
| Failure | Glucantime® | 14 | participants | ||
| Failure | Thermotherapy | 42 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Miltefosine | 145 | |
| Overall Study | STARTED | Glucantime® | 143 | |
| Overall Study | STARTED | Thermotherapy | 149 | |
| Overall Study | COMPLETED | Miltefosine | 121 | |
| Overall Study | COMPLETED | Glucantime® | 121 | |
| Overall Study | COMPLETED | Thermotherapy | 134 | |
| Overall Study | NOT COMPLETED | Miltefosine | 24 | |
| Overall Study | NOT COMPLETED | Glucantime® | 22 | |
| Overall Study | NOT COMPLETED | Thermotherapy | 15 |
Source ClinicalTrials.gov
Adverse events102
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 | Fever (Middle of treatment) | General disorders | Miltefosine | 8 | 130 | 8 |
| other | Fever (Middle of treatment) | General disorders | Glucantime® | 11 | 119 | 11 |
| other | Fever (Middle of treatment) | General disorders | Thermotherapy | 4 | 124 | 4 |
| other | Myalgia (Middle of treatment) | Musculoskeletal and connective tissue disorders | Miltefosine | 9 | 130 | 9 |
| other | Myalgia (Middle of treatment) | Musculoskeletal and connective tissue disorders | Glucantime® | 12 | 119 | 12 |
| other | Myalgia (Middle of treatment) | Musculoskeletal and connective tissue disorders | Thermotherapy | 3 | 124 | 3 |
| other | Arthralgia (Middle of treatment) | Musculoskeletal and connective tissue disorders | Miltefosine | 9 | 130 | 9 |
| other | Arthralgia (Middle of treatment) | Musculoskeletal and connective tissue disorders | Glucantime® | 17 | 119 | 17 |
| other | Arthralgia (Middle of treatment) | Musculoskeletal and connective tissue disorders | Thermotherapy | 3 | 124 | 3 |
| other | Cephalea (Middle of treatment) | General disorders | Miltefosine | 23 | 130 | 23 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Miltefosine | ||
| Total, all-cause mortality | Glucantime® | ||
| Total, all-cause mortality | Thermotherapy | ||
| Total, other adverse events | Miltefosine | 125 | 145 |
| Total, other adverse events | Glucantime® | 121 | 143 |
| Total, other adverse events | Thermotherapy | 110 | 149 |
| Total, serious adverse events | Miltefosine | 1 | 145 |
| Total, serious adverse events | Glucantime® | 3 | 143 |
| Total, serious adverse events | Thermotherapy | 0 | 149 |
Source ClinicalTrials.gov
Papers47
The papers the trial lists on ClinicalTrials.gov.
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/NCT00471705
GET https://conductscience.org/api/trials/v1/NCT00471705/events?page=2