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CompletedNCT00120523Updated Feb 11, 2022Results posted

5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis

A Phase 3 interventional study of Pimecrolimus and Topical corticosteroids in Atopic Dermatitis, sponsored by MEDA Pharma GmbH & Co. KG. Completed at 31 sites in 2 countries. Open to participants aged 3 Months to 12 Months. Per ClinicalTrials.gov, last updated 2022-02-11.

Sponsored by MEDA Pharma GmbH & Co. KG · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,418
Allocation
Randomized
Ages
3 Months to 12 Months
Sex
All
01

Study summary

The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic dermatitis, children, infants, pimecrolimus
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 2,418 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

MEDA Pharma GmbH & Co. KG is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 3 to \< 12 months
  • Diagnosis of AD fulfilling the diagnostic criteria of Seymour
  • AD affecting at least 5% total body surface area
  • Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
  • Topical tacrolimus or pimecrolimus within 2 weeks
  • Topical therapy (e.g., tar, topical corticosteroids) within 3 days
  • Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
  • Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
  • Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
  • Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
  • Clinical conditions other than AD that according to investigator can interfere with the evaluation
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,418 participants (actual)

Study arms

  • Experimental
    1

    Pimecrolimus

    Drug: Pimecrolimus

  • Active comparator
    2

    Topical corticosteroids

    Drug: Topical corticosteroids

Interventions

  • DrugPimecrolimus

    Pimecrolimus cream 1 %

    Also known as: Elidel

  • DrugTopical corticosteroids

    TCS

06

What researchers measure

Primary outcomes

  1. Safety Assessed by Adverse Events

    crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period

    Time frame: throughout the 5-year study

  2. Growth Velocity (Height)

    Time frame: throughout the 5-year study

  3. Growth Velocity (Weight)

    Time frame: throughout the 5-year study

  4. Potential Effect on the Developing Immune System

    number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.

    Time frame: throughout the 5-year study

Secondary outcomes

  1. Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate

    IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI\<0 is set to 0, upper CI\>100 is set to 100. Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.

    Time frame: throughout the 5-year study

  2. Body Surface Area Involved With Atopic Dermatitis

    TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.

    Time frame: throughout the 5-year study

  3. Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)

    PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US. For the purposes of data presentation, a "Not True" response was coded a value of zero and a "True" a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.

    Time frame: throughout the 5-year study

  4. Vital Signs and Physical Examinations: Blood Pressure (BP)

    Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

    Time frame: throughout the 5-year study

  5. Vital Signs and Physical Examinations: Pulse

    Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

    Time frame: throughout the 5-year study

07

Results

Posted Jan 16, 2013

Participant flow

First patient was enrolled into the study on 05 Apr 2004, last patient completed on 04 Oct 2010.

Treatment Period
Participant flow — Treatment Period
MilestonePimecrolimusTopical Corticosteroids
Started12051213
Completed836874
Not completed369339
Follow-Up Period
Participant flow — Follow-Up Period
MilestonePimecrolimusTopical Corticosteroids
Started12070
Completed9046
Not completed3024

Outcome measures

PrimarySafety Assessed by Adverse Events

crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period

Time frame:
throughout the 5-year study
Reported as:
Number · percentage of participants
Safety Assessed by Adverse Events
percentage of participantsPimecrolimusTopical Corticosteroids
Acute tonsillitis8.67.8
Allergy to arthropod bite5.94.9
Arthropod bite7.18.8
Asthma15.114.6
Bronchiolitis5.45.7
Bronchitis36.333.8
Bronchospasm5.26.7
Conjunctivitis16.516.2
Conjunctivitis allergic5.06.3
Constipation6.96.7
Cough29.930.4
Dermatitis diaper12.511.3
Diarrhoea31.931.4
Eczema infected7.44.5
Eye infection0.30.3
Food allergy7.46.0
Gastroenteritis28.227.1
Gastroenteritis viral6.15.2
Heat rash5.54.8
Hypersensitivity2.01.9
Immunisation reaction6.55.5
Impetigo11.910.4
Influenza6.95.7
Influenza like illness16.716.6
Laryngitis5.44.9
Lower respiratory tract infection3.74.5
Molluscum contagiosum9.08.2
Nasopharyngitis59.058.9
Otitis media34.731.7
Otitis media acute12.411.6
Pharyngitis17.819.0
Pneumonia11.010.8
Pyrexia48.949.9
Rhinitis13.913.4
Rhinitis allergic13.212.7
Rhinorrhoea6.86.8
Sinusitis7.68.1
Teething14.914.9
Tonsillitis16.916.5
Upper respiratory tract infection32.031.2
Urinary tract infection4.35.2
Urticaria9.510.6
Varicella25.423.4
Viral rash3.04.1
Viral upper respiratory tract infection10.510.4
Vomiting22.521.3
Wheezing5.65.3
PrimaryGrowth Velocity (Height)
Time frame:
throughout the 5-year study
Reported as:
Mean · cm
Growth Velocity (Height)
cmPimecrolimusTopical Corticosteroids
Baseline (n=1204, n=1208)68.8 ± 5.2668.8 ± 5.14
Week 6 (n=1144, n=1141)71.3 ± 4.8271.3 ± 4.76
Week 26 (n=1092, n=1114)77.0 ± 4.3776.9 ± 4.46
Week 52 (n=999, n=1052)83.1 ± 4.2383.1 ± 4.30
Week 104 (n=924, n=975)93.0 ± 4.3192.9 ± 4.30
Week 156 (n=871, n=919)100.5 ± 4.70100.6 ± 4.72
Week 208 (n=843, n=869)107.7 ± 5.46107.8 ± 5.25
Week 260 (n=833, n=871)114.4 ± 5.26114.5 ± 5.90
PrimaryGrowth Velocity (Weight)
Time frame:
throughout the 5-year study
Reported as:
Mean · kg
Growth Velocity (Weight)
kgPimecrolimusTopical Corticosteroids
Baseline (n=1203, n=1213)8.2 ± 1.518.2 ± 1.51
Week 6 (n=1144, n=1144)8.8 ± 1.458.7 ± 1.41
Week 26 (n=1093, n=1114)10.2 ± 1.4310.1 ± 1.39
Week 52 (n=1003, n=1054)11.6 ± 1.5211.6 ± 1.54
Week 104 (n=928, n=978)14.1 ± 1.9014.1 ± 1.83
Week 156 (n=873, n=924)16.3 ± 2.3216.3 ± 2.29
Week 208 (n=843, n=870)18.6 ± 2.8018.7 ± 2.88
Week 260 (n=833, n=871)21.1 ± 3.5121.4 ± 3.70
SecondaryInvestigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate

IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI\<0 is set to 0, upper CI\>100 is set to 100. Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.

Time frame:
throughout the 5-year study
Reported as:
Number · percentage of participants
Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
percentage of participantsPimecrolimusTopical Corticosteroids
Overall IGA Week 661.4 (58.5 to 64.2)59.6 (56.8 to 62.5)
Overall IGA Week 2666.4 (63.6 to 69.2)74.5 (71.9 to 77.0)
Overall IGA Week 5273.9 (71.2 to 76.6)79.6 (77.2 to 82.1)
Overall IGA Week 10479.9 (77.3 to 82.4)83.4 (81.0 to 85.7)
Overall IGA Week 15681.9 (79.3 to 84.4)86.1 (83.9 to 88.3)
Overall IGA Week 20886.2 (83.8 to 88.5)88.1 (86.0 to 90.2)
Overall IGA Week 26088.7 (86.6 to 90.9)92.3 (90.5 to 94.1)
Facial IGA Week 668.9 (66.3 to 71.6)71.0 (68.4 to 73.6)
Facial IGA Week 2679.5 (77.1 to 81.9)83.8 (81.6 to 86.0)
Facial IGA Week 5285.6 (83.4 to 87.7)88.5 (86.6 to 90.4)
Facial IGA Week 10492.1 (90.4 to 93.9)94.1 (92.6 to 95.6)
Facial IGA Week 15694.2 (92.6 to 95.7)94.3 (92.8 to 95.8)
Facial IGA Week 20896.0 (94.7 to 97.3)96.2 (95.0 to 97.5)
Facial IGA Week 26096.6 (95.4 to 97.9)97.2 (96.2 to 98.3)
SecondaryBody Surface Area Involved With Atopic Dermatitis

TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.

Time frame:
throughout the 5-year study
Reported as:
Mean · percentage of TBSA affected
Body Surface Area Involved With Atopic Dermatitis
percentage of TBSA affectedPimecrolimusTopical Corticosteroids
Baseline (n=1205, n=1213)21.1 ± 16.5021.3 ± 17.19
Week 6 (n=1142, n=1138)5.5 ± 8.726.0 ± 9.10
Week 26 (n=1091, n=1113)4.3 ± 8.303.7 ± 8.50
Week 52 (n=997, n=1048)3.5 ± 7.692.7 ± 6.27
Week 104 (n=922, n=975)2.4 ± 6.531.8 ± 5.17
Week 156 (n=871, n=918)2.0 ± 5.461.4 ± 4.65
Week 208 (n=843, n=868)1.5 ± 5.161.2 ± 4.33
Week 260 (n=833, n=870)1.1 ± 3.310.9 ± 3.69
SecondaryParent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)

PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US. For the purposes of data presentation, a "Not True" response was coded a value of zero and a "True" a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.

Time frame:
throughout the 5-year study
Reported as:
Mean · units on a scale
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
units on a scalePimecrolimusTopical Corticosteroids
Baseline (n=406, n=405)8.1 ± 5.048.4 ± 5.25
Week 6 (n=378, n=360)5.8 ± 4.766.0 ± 5.09
Week 26 (n=368, n=363)4.8 ± 4.735.0 ± 4.85
Week 52 (n=327, n=334)4.2 ± 4.454.4 ± 4.94
Week 104 (n=302, n=296)3.7 ± 4.693.9 ± 5.14
Week 156 (n=269, n=266)3.2 ± 4.673.4 ± 5.02
Week 208 (n=254, n=256)2.7 ± 3.933.0 ± 4.88
Week 260 (n=249, 249)2.1 ± 3.222.3 ± 3.80
SecondaryVital Signs and Physical Examinations: Blood Pressure (BP)

Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

Time frame:
throughout the 5-year study
Reported as:
Mean · mmHg
Vital Signs and Physical Examinations: Blood Pressure (BP)
mmHgPimecrolimusTopical Corticosteroids
Systolic BP - Baseline94.3 ± 12.4094.7 ± 12.79
Systolic BP- Week 696.1 ± 11.7096.3 ± 11.33
Systolic BP- Week 2698.6 ± 11.4698.4 ± 11.49
Systolic BP- Week 5299.0 ± 11.3399.3 ± 11.02
Systolic BP- Week 10498.8 ± 10.0197.9 ± 9.85
Systolic BP- Week 15699.0 ± 9.4798.6 ± 9.75
Systolic BP- Week 20899.8 ± 10.1099.4 ± 9.74
Systolic BP- Week 260100.0 ± 9.51100.1 ± 9.63
Diastolic BP - Baseline59.2 ± 10.4059.1 ± 10.26
Diastolic BP - Week 660.4 ± 9.4761.0 ± 9.59
Diastolic BP - Week 2661.7 ± 9.9061.6 ± 9.78
Diastolic BP - Week 5261.9 ± 9.1261.9 ± 9.23
Diastolic BP - Week 10461.8 ± 8.1461.7 ± 7.72
Diastolic BP - Week 15662.0 ± 8.1162.0 ± 8.29
Diastolic BP - Week 20862.4 ± 8.5261.8 ± 7.77
Diastolic BP - Week 26061.9 ± 7.2462.2 ± 7.38
PrimaryPotential Effect on the Developing Immune System

number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.

Time frame:
throughout the 5-year study
Reported as:
Number · % of patients with positive ab titer
Potential Effect on the Developing Immune System
% of patients with positive ab titerPimecrolimusTopical Corticosteroids
Tetanus Baseline81.885.2
Tetanus week 2689.590.4
Tetanus week 5291.994.0
Tetanus week 10491.994.7
Tetanus week 15693.592.5
Tetanus week 20889.089.5
Tetanus week 26091.188.9
Hepatitis B Baseline57.553.6
Hepatitis B week 2660.758.6
Hepatitis B week 5259.058.5
Hepatitis B week 10451.551.3
Hepatitis B week 15648.545.0
Hepatitis B week 20839.738.5
Hepatitis B week 26034.638.2
Measles Baseline11.414.4
Measles week 2637.431.6
Measles week 5286.386.1
Measles week 10497.397.4
Measles week 15698.597.0
Measles week 20897.895.6
Measles week 26098.996.3
Varicella Baseline32.117.8
Varicella week 2646.545.2
Varicella week 5272.274.2
Varicella week 10478.488.7
Varicella week 15668.481.8
Varicella week 20886.189.4
Varicella week 26087.184.1
SecondaryVital Signs and Physical Examinations: Pulse

Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

Time frame:
throughout the 5-year study
Reported as:
Mean · bpm
Vital Signs and Physical Examinations: Pulse
bpmPimecrolimusTopical Corticosteroids
Baseline116.7 ± 19.43116.0 ± 19.69
Week 6114.2 ± 18.19114.5 ± 19.45
Week 26111.4 ± 18.09111.7 ± 18.44
Week 52107.7 ± 18.63107.0 ± 17.92
Week 104101.7 ± 15.97101.8 ± 15.91
Week 15697.4 ± 13.4597.0 ± 13.72
Week 20893.4 ± 12.7893.4 ± 12.56
Week 26090.2 ± 12.8290.4 ± 12.25

Adverse events

Collected over Adverse event data were collected throughout the study period of 5 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pimecrolimus—247/1,205 (20.5%)1,162/1,205 (96.4%)
Topical Corticosteroids—210/1,213 (17.3%)1,160/1,213 (95.6%)
Most frequent serious events
Showing 10 of 265
Most frequent serious events
EventPimecrolimusTopical Corticosteroids
PneumoniaInfections and infestations22/120528/1213
AsthmaRespiratory, thoracic and mediastinal disorders25/120519/1213
GastroenteritisInfections and infestations20/120524/1213
BronchitisInfections and infestations23/120516/1213
DehydrationMetabolism and nutrition disorders18/12059/1213
BronchopneumoniaInfections and infestations9/120518/1213
VomitingGastrointestinal disorders17/12055/1213
DiarrhoeaGastrointestinal disorders15/12054/1213
Gastroenteritis rotavirusInfections and infestations12/12056/1213
BronchiolitisInfections and infestations7/120512/1213
Most frequent other events
Showing 10 of 44
Most frequent other events
EventPimecrolimusTopical Corticosteroids
NasopharyngitisInfections and infestations711/1205715/1213
PyrexiaGeneral disorders589/1205605/1213
BronchitisInfections and infestations438/1205410/1213
Otitis mediaInfections and infestations418/1205385/1213
Upper respiratory tract infectionInfections and infestations386/1205378/1213
DiarrhoeaGastrointestinal disorders384/1205381/1213
CoughRespiratory, thoracic and mediastinal disorders360/1205369/1213
GastroenteritisInfections and infestations340/1205329/1213
VaricellaInfections and infestations306/1205284/1213
VomitingGastrointestinal disorders271/1205258/1213

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PimecrolimusTopical CorticosteroidsTotal
<=18 years120512132418
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(months)PimecrolimusTopical CorticosteroidsTotal
Mean7.1 ± 2.717.1 ± 2.667.1 ± 2.69
Sex: Female, Male
Sex: Female, Male(Participants)PimecrolimusTopical CorticosteroidsTotal
Female461471932
Male7447421486
Region of Enrollment
Region of Enrollment(participants)PimecrolimusTopical CorticosteroidsTotal
United States106110216
Germany130131261
Argentina404080
Belgium201636
Canada5264116
Chile252247
China6059119
Colombia4852100
Czech Republic262349
Ecuador151328
Spain514899
United Kingdom322759
Greece191635
Guatemala5356109
Hong Kong549
Hungary394079
Iceland9798195
Netherlands5155106
Peru5551106
Poland373673
Portugal5510
Russian Federation5453107
Singapore121325
Sweden292958
Turkey262854
Taiwan303060
Venezuela393978
South Africa4955104
08

Study locations

31 sites
  • Phoenix Children's Hospital
    Phoenix, Arizona 85016, United States
  • Cholla Pediatrics
    Tucson, Arizona 85741, United States
  • Arkansas Pediatric Clinic
    Little Rock, Arkansas 72205, United States
  • Little Rock Allergy & Asthma Clinic
    Little Rock, Arkansas 72205, United States
  • 9540 Artesia Blvd., Suite #1
    Bellflower, California 90706, United States
  • Pediatric Care Medical Group, Inc.
    Huntington Beach, California 92647, United States
  • Longmont Clinical Research
    Longmont, Colorado 80501, United States
  • Children's Skin Center
    Miami, Florida 33155, United States
  • Pediatric Research Center of South Florida
    Palm Beach Gardens, Florida 33458, United States
  • AeroAllergy Research Laboratories of Savanah, Inc.
    Savannah, Georgia 31406, United States
  • The Pediatric Center
    Stone Mountain, Georgia 30083, United States
  • Wayne State University Dermatology
    Detroit, Michigan 48201, United States
  • Michigan State University - Kalamazoo Center for Med Studies
    Kalamazoo, Michigan 49008, United States
  • Respiratory Medicine Research Institute of Michigan
    Ypsilanti, Michigan 48197, United States
  • SMDC Health System
    Duluth, Minnesota 55805, United States
  • Dermatology Center for Children
    Minneapolis, Minnesota 55404, United States
  • University of Minnesota - Dept. of Dermatology
    Minneapolis, Minnesota 55455, United States
  • Radiant Research
    Bridgeton, Missouri 63044, United States
  • Dermatology Associates of Rochester, P.C.
    Rochester, New York 14623, United States
  • Capitol Pediatrics & Adolescent Center
    Raleigh, North Carolina 27609, United States
  • Dermatology Research Associates
    Cincinnati, Ohio 245230, United States
  • Ohio Pediatrics, Inc.
    Huber Heights, Ohio 45424, United States
  • The Portland Clinic
    Beaverton, Oregon 97006, United States
  • Calcagno Research and Development
    Gresham, Oregon 97030, United States
  • Allergy & Asthma Consultants, LLP
    Charleston, South Carolina 29414, United States
  • Allergic Disease and Asthma Center
    Greenville, South Carolina 29607, United States
  • University of Tennessee - Dept. of Pediatrics
    Memphis, Tennessee 38105, United States
  • Suzanne Bruce& Associates, PA
    Houston, Texas 77056, United States
  • Grand Parkway Pediatrics
    Sugar Land, Texas 77479, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
  • Novartis
    Investigative Site, Germany
09

References and documents

Publications

  • Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, Schauer U, Qaqundah P, Poulin Y, Kristjansson S, von Berg A, Nieto A, Boguniewicz M, Paller AS, Dakovic R, Ring J, Luger T. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015 Apr;135(4):597-606. doi: 10.1542/peds.2014-1990. Epub 2015 Mar 23. PubMed 25802354 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00120523
Lead sponsor
MEDA Pharma GmbH & Co. KG
Responsible party
Sponsor
First posted
Jul 18, 2005
Start date
Apr 2004
Primary completion
Oct 2010
Completion
Oct 2010
Results posted
Jan 16, 2013
Last update
Feb 11, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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