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Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Sponsor
OPKO Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01592500
Collaborator
(none)
56
Enrollment
4
Locations
4
Arms
40.9
Duration (Months)
14
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: MOD-4023 low dose

Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)

Drug: MOD-4023
Once weekly subcutaneous injection
Experimental: MOD-4023 middle dose

Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)

Drug: MOD-4023
Once weekly subcutaneous injection
Experimental: MOD-4023 high dose

Once weekly subcutaneous injection of long acting r-hGH (MOD-4023)

Drug: MOD-4023
Once weekly subcutaneous injection
Active Comparator: Genotropin

Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)

Drug: Somatropin
Once daily subcutaneous injection of Genotropin
Other Names:
  • Genotropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Annual Height Velocity [12 months of treatment]

      Annual Height Velocity in cm/year measured after 12 months of treatment

    Secondary Outcome Measures

    1. Height Velocity at 6 Months [After 6 months of treatment]

      Annualized Height Velocity in cm/year measured after 6 months of treatment

    2. Change in Height Standard Deviation Score (SDS) [After 6 and 12 months of treatment]

      Change in height standard deviation score from baseline (compared to normal population of same age group and sex). Height SDS was calculated as height minus reference mean height divided by SD of the reference mean height

    3. Change in IGF-1 Standard Deviation Score [Once monthly on day 4 after the last dose]

      Change in IGF-1 standard deviation score from reference population mean of same age group and sex (WHO source). IGF-1 SDS was calculated as IGF-1 result minus reference mean IGF-1 result divided by SD of the reference mean IGF-1 value.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Pre-pubertal child aged ≥ 3 yrs old and not above 10 years for girls or 11 years for boys with either isolated GHD, or GH insufficiency as part of multiple pituitary hormone deficiency.

    2. Confirmed diagnosis of GHD by two different GH provocation tests defined as a peak plasma GH level of ≤7 ng/ml, determined by central laboratory using a validated assay .

    3. Bone age (BA) is not older than chronological age and should be no greater than 9 years for girls and 10 years for boys.

    4. Without prior exposure to any r-hGH therapy.

    5. Normal birth size, birth weight and length for gestational age

    6. Impaired height and height velocity defined as:

    7. Height (HT) of at least 2.0 standard deviations (SD) below the mean height for chronological age (CA) and gender according to the standards from Prader et. al, 1989 , (HT SDS ≤ -2.0).

    8. Annualized height velocity (HV) below the 25th percentile for CA (HV <-0.7 SDS) and gender according to the standards of Prader et al (1989). The interval between two height measurements should be at least 6 months before inclusion.

    9. BMI must be within ±2 SD of mean BMI for the chronological age and sex according to the 2000 CDC standards.

    10. Baseline IGF-I level of at least 1 SD below the mean IGF-I level standardized for age and sex (IGF-I SDS ≤ -1.0) according to the central laboratory reference values;

      1. Written informed consent of the parent or legal guardian of the patient and assent of the patient (if the patient can read).
    Exclusion Criteria:

    1. Children with past or present intracranial tumor growth as confirmed by an MRI scan (with contrast).

    2. History of radiation therapy or chemotherapy.

    3. Malnourished children defined as:

    4. Serum albumin below the lower limit of normal (LLN) according to the reference ranges of central laboratory;

    5. Serum iron below the lower limit of normal (LLN) according to the reference ranges of central laboratory;

    6. BMI < -2 SD for age and sex;

    7. Children with psychosocial dwarfism.

    8. Children born small for gestational age (SGA - birth weight and/or birth length < -2 SD for gestational age).

    9. Presence of anti-hGH antibodies at screening.

    10. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, etc.

    11. Patients with diabetes mellitus.

    12. Patients with impaired fasting sugar (based on WHO; fasting blood sugar >110 mg/dl or 6.1 mmol/l) after repeated blood analysis.

    13. Chromosomal abnormalities and medical "syndromes" (Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi Syndrome, Russell-Silver Syndrome, SHOX mutations/deletions and skeletal dysplasias), with the exception of septo-optic dysplasia.

    14. Closed epiphyses.

    15. Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids and methylphenidate for attention deficit hyperactivity disorder (ADHD), with the exception of hormone replacement therapies (thyroxine, hydrocortisone, desmopressin (DDAVP))

    16. Children requiring glucocorticoid therapy (e.g. asthma) who are taking a dose of greater than 400 µg/d of inhaled budesonide or equivalents for longer than 1 month during a calendar year.

    17. Major medical conditions and/or presence of contraindication to r-hGH treatment.

    18. Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis.

    19. Drug, substance, or alcohol abuse.

    20. Known hypersensitivity to the components of study medication.

    21. Other causes of short stature such as coeliac disease, hypothyroidism and rickets.

    22. The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct.

    23. Participation in any other trial of an investigational agent within 30 days prior to Screening.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital "P. A. Kyriakou" Athens Greece
    2 Buda Children's Hospital Budapest Hungary
    3 Heim Pal Children's Hospital Budapest Hungary
    4 Children's University Hospital Kosice Slovakia

    Sponsors and Collaborators

    • OPKO Health, Inc.

    Investigators

    • Principal Investigator: Zvi Zadik, MD, Kaplan Medical Center, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    OPKO Health, Inc.
    ClinicalTrials.gov Identifier:
    NCT01592500
    Other Study ID Numbers:
    • CP-4-004
    • 2011-004553-60
    First Posted:
    May 7, 2012
    Last Update Posted:
    Jan 23, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by OPKO Health, Inc.
    GHD
    r-hGH
    Long-acting

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Arm/Group Description Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
    Period Title: Overall Study
    STARTED 14 15 14 13
    COMPLETED 13 15 14 11
    NOT COMPLETED 1 0 0 2

    Baseline Characteristics

    Arm/Group Title MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin Total
    Arm/Group Description Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin) Total of all reporting groups
    Overall Participants 13 15 14 11 53
    Age (Count of Participants)
    <=18 years
    13
    100%
    15
    100%
    14
    100%
    11
    100%
    53
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    3
    23.1%
    6
    40%
    5
    35.7%
    3
    27.3%
    17
    32.1%
    Male
    10
    76.9%
    9
    60%
    9
    64.3%
    8
    72.7%
    36
    67.9%

    Outcome Measures

    1. Primary Outcome
    Title Annual Height Velocity
    Description Annual Height Velocity in cm/year measured after 12 months of treatment
    Time Frame 12 months of treatment

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population
    Arm/Group Title MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Arm/Group Description Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
    Measure Participants 13 15 13 11
    Mean (Standard Deviation) [cm/year]
    10.4
    (2.6)
    11.0
    (2.3)
    11.9
    (3.5)
    12.5
    (2.1)
    2. Secondary Outcome
    Title Height Velocity at 6 Months
    Description Annualized Height Velocity in cm/year measured after 6 months of treatment
    Time Frame After 6 months of treatment

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population
    Arm/Group Title MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Arm/Group Description Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
    Measure Participants 13 15 13 11
    Mean (Standard Deviation) [cm/year]
    11.8
    (3.6)
    12.5
    (2.4)
    13.5
    (5.0)
    15.0
    (2.9)
    3. Secondary Outcome
    Title Change in Height Standard Deviation Score (SDS)
    Description Change in height standard deviation score from baseline (compared to normal population of same age group and sex). Height SDS was calculated as height minus reference mean height divided by SD of the reference mean height
    Time Frame After 6 and 12 months of treatment

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population
    Arm/Group Title MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Arm/Group Description Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
    Measure Participants 13 15 13 11
    After 6 months of treatment
    0.65
    (0.36)
    0.75
    (0.25)
    0.90
    (0.39)
    1.00
    (0.35)
    After 12 months of treatment
    1.09
    (0.53)
    1.19
    (0.49)
    1.45
    (0.61)
    1.51
    (0.47)
    4. Secondary Outcome
    Title Change in IGF-1 Standard Deviation Score
    Description Change in IGF-1 standard deviation score from reference population mean of same age group and sex (WHO source). IGF-1 SDS was calculated as IGF-1 result minus reference mean IGF-1 result divided by SD of the reference mean IGF-1 value.
    Time Frame Once monthly on day 4 after the last dose

    Outcome Measure Data

    Analysis Population Description
    No data were scheduled to be collected for Week 23 in the Genotropin Arm/Group
    Arm/Group Title MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Arm/Group Description Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
    Measure Participants 13 15 14 11
    Week 1
    -1.86
    (0.817)
    -1.94
    (0.899)
    -2.13
    (0.887)
    -2.12
    (0.813)
    Week 10
    -1.03
    (0.902)
    -0.279
    (0.891)
    -0.001
    (1.164)
    -0.515
    (1.238)
    Week 14
    -1.07
    (0.553)
    -0.275
    (0.772)
    -0.058
    (1.067)
    -0.557
    (1.216)
    Week 18
    -0.815
    (0.733)
    0.189
    (0.707)
    -0.083
    (1.299)
    -0.310
    (0.896)
    Week 22
    -0.958
    (0.673)
    -0.188
    (0.684)
    0.023
    (0.964)
    -0.495
    (1.108)
    Week 23
    -1.70
    (0.741)
    -1.48
    (0.653)
    -1.47
    (0.865)
    Week 26
    -0.725
    (0.801)
    0.088
    (0.803)
    -0.011
    (1.084)
    -0.235
    (0.919)
    Month 9
    -0.119
    (0.921)
    0.184
    (0.905)
    0.261
    (1.108)
    0.124
    (1.071)
    Month 12
    -0.458
    (1.194)
    -0.029
    (1.296)
    0.358
    (0.709)
    -0.015
    (1.485)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Arm/Group Description Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once weekly subcutaneous injection of long acting r-hGH (MOD-4023) Once daily subcutaneous injection of Somatropin (r-hGH; Genotropin)
    All Cause Mortality
    MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/13 (0%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Other (Not Including Serious) Adverse Events
    MOD-4023 Low Dose MOD-4023 Middle Dose MOD-4023 High Dose Genotropin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/13 (76.9%) 10/15 (66.7%) 10/14 (71.4%) 8/11 (72.7%)
    Blood and lymphatic system disorders
    Anemia 1/13 (7.7%) 2/15 (13.3%) 3/14 (21.4%) 1/11 (9.1%)
    Iron Deficiency Anemia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Ear and labyrinth disorders
    Vertigo 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Endocrine disorders
    Adrenal Insufficiency 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Hypothyroidism 1/13 (7.7%) 1/15 (6.7%) 1/14 (7.1%) 1/11 (9.1%)
    Secondary Adrenocortical Insufficiency 0/13 (0%) 1/15 (6.7%) 0/14 (0%) 0/11 (0%)
    Eye disorders
    Amblyopia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Astigmatism 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Conjunctivitis 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Eye Inflammation 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Eyelid Oedema 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Hypermetropia 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Gastrointestinal disorders
    Abdominal Pain 0/13 (0%) 1/15 (6.7%) 0/14 (0%) 1/11 (9.1%)
    Acetonaemic Vomiting 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Dental Caries 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Enteritis 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Nausea 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Toothache 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 1/11 (9.1%)
    Vomiting 0/13 (0%) 1/15 (6.7%) 0/14 (0%) 0/11 (0%)
    General disorders
    Asthenia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Chest Pain 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Injection Site Erythema 1/13 (7.7%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Injection Site Haematoma 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Injection Site Pain 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Injection Site Pruritus 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Injection Site Swelling 1/13 (7.7%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Edema Peripheral 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Pyrexia 2/13 (15.4%) 1/15 (6.7%) 0/14 (0%) 1/11 (9.1%)
    Hepatobiliary disorders
    Biliary dyskinesia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Sphincter of Oddi Dysfunction 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Infections and infestations
    Acute Tonsillitis 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Bronchitis 3/13 (23.1%) 0/15 (0%) 0/14 (0%) 2/11 (18.2%)
    Cystitis 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Ear Infection 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Fungal Skin Infection 0/13 (0%) 1/15 (6.7%) 0/14 (0%) 0/11 (0%)
    Gastroenteritis 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Helminthic Infection 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Nasopharyngitis 2/13 (15.4%) 1/15 (6.7%) 0/14 (0%) 2/11 (18.2%)
    Pulpitis Dental 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Respiratory Tract Infection 2/13 (15.4%) 1/15 (6.7%) 2/14 (14.3%) 3/11 (27.3%)
    Respiratory Tract Infection Viral 0/13 (0%) 2/15 (13.3%) 1/14 (7.1%) 1/11 (9.1%)
    Rhinitis 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Sinusitis 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Tracheitis 0/13 (0%) 1/15 (6.7%) 0/14 (0%) 0/11 (0%)
    Tracheobronchitis 0/13 (0%) 1/15 (6.7%) 0/14 (0%) 0/11 (0%)
    Varicella 1/13 (7.7%) 0/15 (0%) 2/14 (14.3%) 0/11 (0%)
    Viral Infection 0/13 (0%) 1/15 (6.7%) 0/14 (0%) 0/11 (0%)
    Injury, poisoning and procedural complications
    Accidental Overdose 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Meniscus Cyst 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Investigations
    Body Temperature Increased 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Hemoglobin Decreased 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Insulin-Like Growth Factor Increased 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Red Blood Cell Count Decreased 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Thyroxine Decreased 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 1/11 (9.1%)
    Metabolism and nutrition disorders
    Hypercalcaemia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Hypoglycaemia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Impaired Fasting Glucose 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Back Pain 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Connective Tissue Disorder 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Pain in Extremity 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin Papilloma 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Nervous system disorders
    Headache 4/13 (30.8%) 1/15 (6.7%) 0/14 (0%) 1/11 (9.1%)
    Psychiatric disorders
    Attention Deficit/Hyperactivity Disorder 0/13 (0%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Renal and urinary disorders
    Hematuria 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/13 (7.7%) 1/15 (6.7%) 0/14 (0%) 0/11 (0%)
    Nasal Congestion 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 1/11 (9.1%)
    Rhinitis Allergic 0/13 (0%) 1/15 (6.7%) 1/14 (7.1%) 0/11 (0%)
    Snoring 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis Atopic 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Petechia 1/13 (7.7%) 0/15 (0%) 0/14 (0%) 0/11 (0%)
    Urticaria 0/13 (0%) 0/15 (0%) 1/14 (7.1%) 0/11 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There IS 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 OPKO Health Inc
    Organization OPKO Health Inc
    Phone 3055754100
    Email contact@opko.com
    Responsible Party:
    OPKO Health, Inc.
    ClinicalTrials.gov Identifier:
    NCT01592500
    Other Study ID Numbers:
    • CP-4-004
    • 2011-004553-60
    First Posted:
    May 7, 2012
    Last Update Posted:
    Jan 23, 2020
    Last Verified:
    Jan 1, 2020