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Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

Sponsor
Universidad de Antioquia (Other)
Overall Status
Completed
CT.gov ID
NCT00471705
Collaborator
Dirección de Sanidad del Ejército de Colombia (DISAN) (Other), Ministerio de Salud y Protección Social, Colombia (Other)
437
Enrollment
1
Location
3
Arms
42
Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000 new cases of CL were diagnosed in Colombia.

So far, pentavalent antimony compounds have been considered the treatment of choice with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their adverse events and disadvantages. Previous studies have shown that miltefosine could be a potential alternative of treatment for CL.

The main objective of this study is to evaluate the efficacy and safety of miltefosine or thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50 celsius degrees during 30 seconds will be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days in CL parasitologically proven patients.

This trial will be conducted according to the International approved GCP (Good Clinical Practice) guidelines.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Evaluation of Efficacy and Safety of Miltefosine for Cutaneous Leishmaniasis in Colombia Leishmaniasis is taking dramatic dimensions in Colombia, due to its rapid expansion, reemergence (which has made Colombia became in the second South American country in levels of annual incidence) the appearance of new infection sources, the entrance of the vector to the homes, the urbanization of the disease, the higher population in risk of infection, the absence of adequate medications ( safe, non-expensive, easily available, with oral or topic route of administration) and the higher resistance to the only available medication for its treatment. It is estimated that in 2005 more than 20,000 new cases were diagnosed; 10,265 of them among the Colombian military forces personnel, but it is well known that in most of the rural areas the major proportion of cases are not diagnosed and the people cannot reach to an adequate treatment and they have to use empiric options.

On the other hand, the Program for Research and Control in tropical diseases (PECET) is working among Tropical Diseases Research/World Health Organization(TDR/WHO) in the evaluation of drugs and vaccines against Leishmaniasis; besides, PECET belongs to the TDR/WHO Clinical Monitors groups, TDR/WHO Data Management and participates in the Initiative for Public Health Products Development Doctorate among five Asiatic universities. The Ministry of Social Protection is aware of the need of new therapeutic alternatives for Leishmaniasis and has requested to PECET to conduct a controlled clinical trial to determinate the efficacy and safety of Miltefosine compared with Glucantime for the treatment of Cutaneous Leishmaniasis (CL) in Colombia, even though previous, no conclusive trials, conducted in Guatemala and Colombia, have demonstrated efficacy this could be an alternative of treatment for this country.

Thermomed is a battery-operated medical device that delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue. Radio frequency energy is directed through the handset to the applicator that is placed in direct contact with the lesion. (the applicator contains a thermocouple to continuously monitor and control temperature to within 50º Celsius. The thermomed has been used for research on treatment for cutaneous leishmaniasis, and recent clinical studies have shown not only clinical improvement, but also that therapy elicits an immune response to the disease. Through this trial we will try to perform a conclusive clinical evaluation about this drug.

In summary, with this project to conduct a clinical trial to determine the efficacy and safety of Miltefosine or thermotherapy compared with Glucantime for treatment of CL in Colombian patients.

Population CL in is a remerging disease in Colombia affecting civilian and military population as well, sharing the same epidemiologic characteristics.

The selected population will be composed from National Army of Colombia soldiers from CL endemic areas (Caquetá, Meta, Guaviare, Putumayo, Córdoba, Antioquia and Chocó).

Treatment:

In this phase III, randomized open trial, subjects meeting inclusion criteria of the trial will be randomly allocated into two groups according to a randomization list. One group will be treated with 150 mg/day of oral miltefosine for 28 days a second group will be treated with thermotherapy device used for one session at 50 celsius degrees during 30 seconds and a third group will be treated with intramuscular injections of 20 mg/kg/day Glucantime® for 20 days. A written instruction sheet will be given to each included patient, and the patient will be instructed to contact the research team on appearance of symptoms suggesting severe side effects (intractable diarrhea and/or vomiting, symptoms of liver, kidney or hematopoietic system dysfunction. Until six weeks after the termination of the treatment, any patient who received oral miltefosine or was treated with thermotherapy and has active lesion will be treated with intramuscular Glucantime® injections (20mg/kg/day for 20 days).

Study development Schedule of activities Screening (-2 or day 0): Protocol explanation, invitation to participate, inform consent signature, parasitological diagnosis (Direct test), laboratory tests (Complete hemogram, Ureic Nitrogen (BUN), creatinine, amylase, Glutamic-pyruvic transaminase(GTP or ALT), glutamic-oxaloacetic transaminase(GOT or AST)).

Inclusion (Visit 1): Randomization, sampling of Cultures, physical examination, vital signs measure, oral treatment initiation (Miltefosine for 28 days) or Glucantime® intramuscular application initiation (for the 20 subsequent days) or thermotherapy ( Local heat), patient's clinical record, CRF (Case Report Format) fulfilling, lesions picture taking.

Visit 2 (Middle of treatment): Laboratory tests (Complete hemogram, BUN, creatinine, amylase, GOT, GPT), physical examination, vital signs measure, CRF (Case Report Format) fulfilling, Lesions picture taking.

Visit 3 (End of treatment, +10 days): Laboratory tests (Complete hemogram, BUN, creatinine, amylase, GTP, GOT), physical examination, vital signs measure, CRF (Case Report Format) fulfilling, lesions picture taking, Evaluation of treatment efficacy.

Visit 4 (Six weeks after treatment, ± 15 days): Physical examination, Vital signs measure, CRF (Case Report Format) fulfilling, lesions picture taking, evaluation of treatment efficacy.

Visit 5 (Three months after treatment, ± 30 days): Physical examination, Vital signs measure, CRF (Case Report Format) fulfilling, lesions picture taking, evaluation of treatment efficacy.

Visit 6 (Six months after treatment, ± 40 days): Physical examination, Vital signs measure, CRF (Case Report Format) fulfilling, lesions picture taking, evaluation of treatment efficacy.

Procedures:

Physical examination A complete physical examination will be realized and vital signs will be measured.

Blood samples withdrawn

Blood samples will be withdrawn from the antecubital vein to perform the following analyses:

  • Creatinine and Blood Urea Nitrogen.

  • Alanine transaminase (ALT)

  • Aspartate transaminase (AST)

  • Pancreatic amylase.

  • Complete hemogram.

Technique for the sampling of cultures The sample for the culture may be obtained by suctioning the ulcer active edge in a phosphate-buffered saline solution (PBS) with antibiotics (1000 IU of crystalline Penicillin per cc), before it is put in the culture medium.

A tuberculin syringe 0.5 cc of PBS solution with antibiotics is used in the suction technique. Previous asepsis of the ulcer with alcohol at 70%, a needle is introduced into the dermis and through rotating movements a small amount of tissue is macerated by the needle bevel during about a minute, after which it is suctioned into the syringe. The sample is deposited in aseptic conditions into a NNN (Novy-MacNeal-Nicole ) culture medium and incubated at 26°C during 4 weeks. The strains are identified by species using the monoclonal antibodies.

Toxicity

The grade of toxicity will be evaluated according the following parameters:

  • Systemic: Fever, Headache.

  • Gastrointestinal: Nausea, vomiting, oral discomfort.

  • Cardiovascular: cardiac rhythm, hypertension, hypotension.

  • Musculoskeletal: Arthralgia (joint pain) , myalgia,

During the treatment and the follow-up visits, the patients will be asked about adverse events. Each adverse event will be classified by the physician as serious or non-serious A serious adverse event should meet one or more of the following criteria:

  • Death

  • Life-threatening (i.e., immediate risk of death)

  • In-patient hospitalization or prolongation of existing hospitalization

  • Persistent or significant disability/incapacity The presence of a serious adverse event that puts the patient's life at risk and/or requires immediate medical or surgical procedure will call for the discontinuation of the treatment and the initiation of the pertinent medical management of the patients. The study staff will notify the Adverse IEC/IRB of the University of Antioquia of any serious adverse event within 24 hours of having knowledge of it.

A non-serious adverse event will be classified as follows:

Mild: The patients are aware of their symptoms and/or signs, but those are tolerable. They do not require medical intervention or specific treatment.

Moderate: Patients present troubles that interfere with their daily activities. They require medical intervention or specific treatment.

Severe: The patients are unable to work or to attend their daily activities. They require medical intervention or specific treatment.

The possible relationship between the adverse events and the tested medication will be classified by the investigator on the basis of his/her clinical judgment and the following definitions:

Definitely related: Event can be fully explained by the administration of the tested medication.

Probably related: Event is most likely to be explained by the administration of the tested medication rather than other medications or by the patient's clinical state.

Possibly related: Event may be explained by the administration of the tested medication or other medications or by the patient's clinical state.

Not related: Event is most likely to be explained by the patient's clinical state or other medications, rather than the tested one.

Data analysis phase. The healing rate will be calculated according to each group (treatment and control) by intention to treat and by protocol. Subgroups will be established depending on the clinical response, adverse events and according to Leishmania specie. Besides, the characteristics of the lesion (size, localization, type of lesion), demographic characteristics and how long the healing takes after the treatment is settled.

In all cases significance test will be performed to compare both treatments.

Endpoints Primary Clinical response: Complete re-epithelization of all lesions with disappearance of induration (with or without scar). No parasitological evaluation will be done on clinically cured lesions determined until 45 days posttreatment.

Clinical improvement: Reduction of a ≥50% area of induration and ulcer compared with immediately previous evaluation.

Secondary:

Treatment failure: No change or increase in the size of induration and ulcer. Absence of clinical response: Induration and ulcer area ≤50% compared with the immediately previous evaluation.

Final reports At the end of the study the results will be evaluated and discussed and a final report presented to Colombian army and Ministry of Social Protection, entities sponsoring the project. The relevant results will be published in both, national and international journals, and presented in congresses and scientific meetings.

Ethical aspects This study will be conduced according with the Declaration of Helsinki , the Colombian legislation as per the resolution 008430/93 from the Ministry of Health, Canadian Council of Animal Care, National Institute for drugs and foods vigilance and control - (INVIMA)(Colombia), International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines, and TDR/WHO guidelines for clinical research.

Prior to the admission of the patients in the study, the objectives and the methodology will be explained and informed consent obtained.

The study was approved for the Sede de Investigación Universitaria (SIU) bioethics committee (CBEIH-SIU) and the Leishmaniasis Committee of the Colombian Military Forces.

The right to confidentiality of the patients will be maintained in all the phases of the study.

Competing of interests:

The authors declare that they have no competing of interests.

Study Design

Study Type:
Interventional
Actual Enrollment :
437 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia.
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Miltefosine

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

Drug: Miltefosine
Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
Other Names:
  • Impavido®

    		•
    Active Comparator: Glucantime®

    Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

    Drug: Glucantime®
    Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
    Other Names:
  • Glucantime® (meglumine antimoniate)

    		•
    Experimental: Thermotherapy

    One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

    Device: Thermotherapy
    One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
    Other Names:
  • Thermomed

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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 Outcome Measures

    1. Recurrence [Until 6 months post-treatment]

      Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Parasitologically proven cases of CL based on positive smear and/or culture.

    • Patients belonging to the National Colombian Army.

    • Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)

    • Age 18-40 years.

    • Willing to participate in the study, sign the informed consent , to go to the scheduled visits and to the follow-up visits.

    • Abstain to receive any other treatment for CL during the trial and follow-up periods.

    • Non purulent lesions.

    • Mentally sane volunteers.

    • No Leishmaniasis treatment in the six months prior to the recruitment.

    • Number of lesions no more than 5

    Exclusion criteria:

    • None of the lesions must be close to the anal, oral and nasal mucosa, or next to the urogenital and anal canal.

    • Serious systemic illnesses (as judged by the physician)

    • Patients with mucosal compromise.

    • Patients with diffuse Leishmaniasis ( defined as 10 or more cutaneous lesions and negative Montenegro's test)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Program for Research and Control in Tropical Diseases - PECET Medellín Antioquia Colombia 1226

    Sponsors and Collaborators

    • Universidad de Antioquia
    • Dirección de Sanidad del Ejército de Colombia (DISAN)
    • Ministerio de Salud y Protección Social, Colombia

    Investigators

    • Principal Investigator: Ivan D. Vélez, MD. PhD., Program for Research and Control in Tropical Diseases - PECET (Director)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Universidad de Antioquia
    ClinicalTrials.gov Identifier:
    NCT00471705
    Other Study ID Numbers:
    • PECET-001
    First Posted:
    May 10, 2007
    Last Update Posted:
    Jan 16, 2019
    Last Verified:
    Jun 1, 2009
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Universidad de Antioquia
    Miltefosine
    Leishmaniasis
    Glucantime
    Thermotherapy
    Colombia
    Additional relevant MeSH terms:
    Leishmaniasis
    Leishmaniasis, Cutaneous
    Miltefosine
    Meglumine Antimoniate

    Study Results

    Participant Flow

    Recruitment Details The study was carried out between June 2006 and April 2008. The subjects of the study were adult males serving in the Colombian Army. The study was carried out in five military health establishments located in central, northeast and southern Colombia.
    Pre-assignment Detail Screening was performed to 486 volunteers, of whom 49 were excluded for several reasons, as follows: Failure to meet inclusion criteria (n=12), unwillingness to participate (n=14) and completion of military service within 6 months (n=23)
    Arm/Group Title Miltefosine Glucantime® Thermotherapy
    Arm/Group Description Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day. Glucantime® 20 mg /Kg /day for 20 days (intramuscular) One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
    Period Title: Overall Study
    STARTED 145 143 149
    COMPLETED 121 121 134
    NOT COMPLETED 24 22 15

    Baseline Characteristics

    Arm/Group Title Miltefosine Glucantime® Thermotherapy Total
    Arm/Group Description Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day. Glucantime® 20 mg /Kg /day for 20 days (intramuscular) One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds. Total of all reporting groups
    Overall Participants 145 143 149 437
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    23
    23
    23
    23
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    145
    100%
    143
    100%
    149
    100%
    437
    100%
    Region of Enrollment (participants) [Number]
    Colombia
    145
    100%
    143
    100%
    149
    100%
    437
    100%

    Outcome Measures

    1. Primary Outcome
    Title Complete Clinical Response
    Description 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.
    Time Frame Until 6 months posttreatment

    Outcome Measure Data

    Analysis Population Description
    The efficacy of the treatments was calculated by intention to treat and by protocol.
    Arm/Group Title Miltefosine Glucantime® Thermotherapy
    Arm/Group Description Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day. Glucantime® 20 mg /Kg /day for 20 days (intramuscular) One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
    Measure Participants 145 143 149
    Number [participants]
    85
    58.6%
    103
    72%
    86
    57.7%
    2. Secondary Outcome
    Title Recurrence
    Description Reactivation of the lesion at the original site after cure or mucosal compromise during follow-up.
    Time Frame Until 6 months post-treatment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Miltefosine Glucantime® Thermotherapy
    Arm/Group Description Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day. Glucantime® 20 mg /Kg /day for 20 days (intramuscular) One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
    Measure Participants 145 143 149
    Number [Participants]
    3
    2.1%
    4
    2.8%
    6
    4%
    3. Primary Outcome
    Title Failure
    Description 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
    Time Frame Until 3 months posttreatment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Miltefosine Glucantime® Thermotherapy
    Arm/Group Description Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day. Glucantime® 20 mg /Kg /day for 20 days (intramuscular) One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
    Measure Participants 145 143 149
    Number [participants]
    34
    23.4%
    14
    9.8%
    42
    28.2%

    Adverse Events

    Time Frame During treatment and 6 months after treatment
    Adverse Event Reporting Description The Risk population differs across Adverse Events terms because not all lab tests were available at all study sites.
    Arm/Group Title Miltefosine Glucantime® Thermotherapy
    Arm/Group Description Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day. Glucantime® 20 mg /Kg /day for 20 days (intramuscular) One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
    All Cause Mortality
    Miltefosine Glucantime® Thermotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Miltefosine Glucantime® Thermotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/145 (0.7%) 3/143 (2.1%) 0/149 (0%)
    Gastrointestinal disorders
    Hematemesis 1/145 (0.7%) 1 0/143 (0%) 0 0/149 (0%) 0
    Social circumstances
    Death in combat 0/145 (0%) 0 2/143 (1.4%) 2 0/149 (0%) 0
    Stab wound 0/145 (0%) 0 1/143 (0.7%) 1 0/149 (0%) 0
    Other (Not Including Serious) Adverse Events
    Miltefosine Glucantime® Thermotherapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 125/145 (86.2%) 121/143 (84.6%) 110/149 (73.8%)
    Blood and lymphatic system disorders
    Haemoglobin (End of treatment) 1/98 (1%) 1 7/108 (6.5%) 7 2/70 (2.9%) 2
    Haemoglobin (middle of treatment 5/113 (4.4%) 5 5/107 (4.7%) 5 5/96 (5.2%) 5
    Gastrointestinal disorders
    Vomiting (Middle of treatment) 29/130 (22.3%) 29 3/119 (2.5%) 3 3/124 (2.4%) 3
    Nausea (Middle of treatment) 38/130 (29.2%) 38 4/119 (3.4%) 4 5/124 (4%) 5
    Anorexia (Middle of treatment) 19/130 (14.6%) 19 8/119 (6.7%) 8 5/124 (4%) 5
    Vomiting (End of treatment) 44/129 (34.1%) 44 16/131 (12.2%) 16 2/132 (1.5%) 2
    Nausea (End of treatment ) 59/129 (45.7%) 59 27/131 (20.6%) 27 4/132 (3%) 4
    Anorexia (End of treatment ) 37/129 (28.7%) 37 45/131 (34.4%) 45 6/132 (4.5%) 6
    Diarrhea (End of treatment) 6/129 (4.7%) 6 2/131 (1.5%) 2 1/132 (0.8%) 1
    Abdominal Pain (End of treatment) 9/129 (7%) 9 2/131 (1.5%) 2 0/132 (0%) 0
    General disorders
    Fever (Middle of treatment) 8/130 (6.2%) 8 11/119 (9.2%) 11 4/124 (3.2%) 4
    Cephalea (Middle of treatment) 23/130 (17.7%) 23 17/119 (14.3%) 17 10/124 (8.1%) 10
    Fever (End of treatment) 8/129 (6.2%) 8 29/131 (22.1%) 29 4/132 (3%) 4
    Cephalea (End of treatment) 30/129 (23.3%) 30 52/131 (39.7%) 52 13/132 (9.8%) 13
    Hepatobiliary disorders
    ALT (Middle of treatment) 17/132 (12.9%) 17 19/137 (13.9%) 19 8/106 (7.5%) 8
    Amylase (Middle of treatment) 29/112 (25.9%) 29 15/111 (13.5%) 15 6/87 (6.9%) 6
    AST (End of treatment) 5/103 (4.9%) 5 11/111 (9.9%) 11 2/75 (2.7%) 2
    ALT (End of treatment) 15/92 (16.3%) 15 11/90 (12.2%) 11 12/105 (11.4%) 12
    Amylase (End of treatment ) 11/108 (10.2%) 11 24/109 (22%) 24 7/70 (10%) 7
    AST (Middle of treatment) 8/105 (7.6%) 8 8/99 (8.1%) 8 11/93 (11.8%) 11
    Musculoskeletal and connective tissue disorders
    Myalgia (Middle of treatment) 9/130 (6.9%) 9 12/119 (10.1%) 12 3/124 (2.4%) 3
    Arthralgia (Middle of treatment) 9/130 (6.9%) 9 17/119 (14.3%) 17 3/124 (2.4%) 3
    Myalgia (End of treatment) 16/129 (12.4%) 16 67/131 (51.1%) 67 4/132 (3%) 4
    Arthralgia (End of treatment) 13/129 (10.1%) 13 65/131 (49.6%) 65 3/132 (2.3%) 3
    Renal and urinary disorders
    BUN (Middle of treatment) 0/94 (0%) 0 4/99 (4%) 4 1/96 (1%) 1
    BUN (End of treatment) 3/102 (2.9%) 3 1/114 (0.9%) 1 2/78 (2.6%) 2
    Creatinine (middle of treatment) 8/120 (6.7%) 8 12/112 (10.7%) 12 7/87 (8%) 7
    Creatinine (end of treatment) 6/99 (6.1%) 6 1/115 (0.9%) 1 1/81 (1.2%) 1
    Skin and subcutaneous tissue disorders
    Lesion pain (middle of treatment) 14/130 (10.8%) 14 3/119 (2.5%) 3 27/124 (21.8%) 27
    Lesion infection (middle of treatment) 5/130 (3.8%) 5 2/119 (1.7%) 2 9/124 (7.3%) 9
    Lesion pain (end of treatment) 11/129 (8.5%) 11 16/131 (12.2%) 16 18/122 (14.8%) 18

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Iván Darío Vélez Bernal
    Organization Universidad de Antioquia - Colombia
    Phone 574 + 219 6501 - 02
    Email idvelez@pecet-colombia.org
    Responsible Party:
    Universidad de Antioquia
    ClinicalTrials.gov Identifier:
    NCT00471705
    Other Study ID Numbers:
    • PECET-001
    First Posted:
    May 10, 2007
    Last Update Posted:
    Jan 16, 2019
    Last Verified:
    Jun 1, 2009