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Trial record 37 of 39 for:    idiopathic intracranial hypertension

Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00266656
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : August 23, 2016
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Turner Syndrome
Intervention Drug: Humatrope
Enrollment 69
Recruitment Details To be included in this study, participants had to be females with karyotype-proven Turner syndrome who were previously randomized in Study B9R-US-GDFG (NCT00406926).
Pre-assignment Details  
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Period Title: Overall Study
Started 36 33
Completed 22 20
Not Completed 14 13
Reason Not Completed
Death             1             0
Lost to Follow-up             4             1
Withdrawal by Subject             4             2
Did Not Reach Final Height             4             8
Parent/Caregiver Decision             1             2
Arm/Group Title Early Treated Early Untreated Total
Hide Arm/Group Description Early treated n=36 Early untreated n=33 Total of all reporting groups
Overall Number of Baseline Participants 36 33 69
Hide Baseline Analysis Population Description
All enrolled/started participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 33 participants 69 participants
8.29  (1.22) 8.41  (1.30) 8.35  (1.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 33 participants 69 participants
Female
36
 100.0%
33
 100.0%
69
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 36 participants 33 participants 69 participants
124.34  (10.08) 121.06  (9.76) 122.77  (9.99)
Height Standard Deviation Score (SDS)  
Mean (Standard Deviation)
Unit of measure:  Standard Deviation Score
Number Analyzed 36 participants 33 participants 69 participants
-0.84  (1.22) -1.48  (1.23) -1.15  (1.26)
Bone Age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 33 participants 69 participants
8.73  (1.55) 8.34  (1.57) 8.54  (1.56)
1.Primary Outcome
Title Most Mature Height Standard Deviation Score (SDS)
Hide Description SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Time Frame Baseline through End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: standard deviation score
-1.37  (1.09) -1.60  (1.21)
2.Secondary Outcome
Title Height SDS at Various Ages
Hide Description SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Time Frame Age 10, Age 13, Age 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a baseline visit and at least one post-baseline visit.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: Standard deviation score
Age 10 (n=32, 30) -0.66  (1.16) -1.28  (1.17)
Age 13 (n=29, 29) -1.29  (1.24) -1.87  (1.16)
Age 16 (n=18, 18) -1.66  (1.11) -1.69  (1.30)
3.Secondary Outcome
Title Age at Attainment of Tanner 2 Breast Development
Hide Description The Tanner 2 breast development is the age at first evidence of breast development.
Time Frame Baseline through End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a baseline visit and at least one post-baseline visit.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 35 32
Mean (Standard Error)
Unit of Measure: years
11.80  (0.26) 12.14  (0.31)
4.Secondary Outcome
Title Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years
Hide Description Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.
Time Frame Baseline through End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 25 26
Mean (Standard Error)
Unit of Measure: years
14.64  (0.25) 15.26  (0.23)
5.Secondary Outcome
Title Reports of Serious Adverse Events
Hide Description

Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria).

A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time Frame Baseline through End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: events
8 5
6.Secondary Outcome
Title Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events
Hide Description Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.
Time Frame Baseline through End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Ear infections 13.9 18.2
Baseline High Blood Pressure 0 3
Baseline Hypothyroidism 13.9 6.1
Baseline Scoliosis 22.2 9.1
Year 1 Ear infections 38.9 39.4
Year 1 High Blood Pressure 0 3
Year 1 Hypothyroidism 11.1 12.1
Year 1 Scoliosis 16.7 21.2
Year 2 Diabetes 2.8 0
Year 2 Dilatation of the Aorta 0 3
Year 2 Ear infections 33.3 27.3
Year 2 High Blood Pressure 0 3
Year 2 Hypothyroidism 11.1 12.1
Year 2 Scoliosis 22.2 24.2
Year 3 Diabetes 2.8 0
Year 3 Dilatation of the Aorta 0 6.1
Year 3 Ear infections 30.6 36.4
Year 3 High Blood Pressure 0 3
Year 3 Hypothyroidism 11.1 12.1
Year 3 Scoliosis 25.0 27.3
Year 4 Diabetes 2.8 0
Year 4 Dilatation of the Aorta 0 6.1
Year 4 Ear infections 16.7 30.3
Year 4 High Blood Pressure 0 3
Year 4 Hypothyroidism 11.1 12.1
Year 4 Scoliosis 25.0 27.3
Year 5 Diabetes 2.8 0
Year 5 Dilatation of the Aorta 0 6.1
Year 5 Ear infections 22.2 27.3
Year 5 High Blood Pressure 0 3
Year 5 Hypothyroidism 13.9 18.2
Year 5 Scoliosis 25.0 27.3
Year 6 Diabetes 2.8 0
Year 6 Dilatation of the Aorta 0 9.1
Year 6 Ear infections 19.4 24.2
Year 6 High Blood Pressure 0 3
Year 6 Hypothyroidism 13.9 18.2
Year 6 Scoliosis 16.7 30.3
Year 7 Diabetes 2.8 0
Year 7 Dilatation of the Aorta 0 9.1
Year 7 Ear infections 19.4 18.2
Year 7 High Blood Pressure 0 3
Year 7 Hypothyroidism 13.9 15.2
Year 7 Scoliosis 13.9 30.3
Year 8 Diabetes 2.8 0
Year 8 Dilatation of the Aorta 2.8 9.1
Year 8 Ear infections 13.9 18.2
Year 8 High Blood Pressure 0 3
Year 8 Hypothyroidism 5.6 12.1
Year 8 Scoliosis 13.9 33.3
Year 9 Dilatation of the Aorta 0 3
Year 9 Ear infections 2.8 3.0
Year 9 High Blood Pressure 0 3
Year 9 Hypothyroidism 2.8 6.1
Year 9 Scoliosis 5.6 9.1
Year 10 Scoliosis 2.8 0
7.Secondary Outcome
Title Percentage of Participants With Abnormal Tympanometry Results
Hide Description Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint.
Time Frame Baseline, Age 10, Age 16, End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Right Ear 44.4 54.5
Baseline Left Ear 47.2 45.5
Age 10 Right Ear 27.8 15.2
Age 10 Left Ear 27.8 15.2
Age 16 Right Ear 2.8 9.1
Age 16 Left Ear 2.8 3.0
Endpoint Right Ear 8.3 12.1
Endpoint Left Ear 11.1 9.1
8.Secondary Outcome
Title Percentage of Participants With Prevalence of Abnormal Audiometry Results
Hide Description Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.
Time Frame Baseline, Age 10, Age 16, End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Visit (n=36, 33) 52.8 48.5
Age 10 (n=27, 24) 44.4 29.2
Age 16 (n=7, 9) 85.7 66.7
Endpoint (n=24, 22) 37.5 40.9
9.Secondary Outcome
Title Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)
Hide Description Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.
Time Frame Baseline, Age 10, Age 16, End of Study (10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description:

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

Overall Number of Participants Analyzed 36 33
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Left Ear Air (n=36, 32) 30.6 31.3
Baseline Left Ear Bone (n=36, 32) 2.8 0.0
Baseline Right Ear Air (n=36, 32) 22.2 37.5
Baseline Right Ear Bone (n=36, 32) 22.2 2.8
Age 10 Left Ear Air (n=27, 21) 29.6 14.3
Age 10 Left Ear Bone (n=27, 21) 0.0 0.0
Age 10 Right Ear Air (n=27, 22) 14.8 18.2
Age 10 Right Ear Bone (n=27, 22) 0.0 9.1
Age 16 Left Ear Air (n=7, 9) 57.1 66.7
Age 16 Left Ear Bone (n=7, 9) 0.0 0.0
Age 16 Right Ear Air (n=7, 9) 28.6 33.3
Age 16 Right Ear Bone (n=7, 9) 0.0 22.2
Endpoint Left Ear Air (n=20, 20) 30.0 35.0
Endpoint Left Ear Bone (n=20, 20) 5.0 20.0
Endpoint Right Ear Air (n=20, 20) 20.0 35.0
Endpoint Right Ear Bone (n=20, 20) 10.0 25.0
Time Frame [Not Specified]
Adverse Event Reporting Description All enrolled/started participants.
 
Arm/Group Title Early Treated Early Untreated
Hide Arm/Group Description

Humatrope administered according to investigator's clinical practice and guided by the approved package insert.

Humatrope administered in B9R-US-GDFG (NCT00406926).

Humatrope administered according to investigator's clinical practice and guided by the approved package insert.

Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926).

All-Cause Mortality
Early Treated Early Untreated
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Early Treated Early Untreated
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/36 (16.67%)      5/33 (15.15%)    
Congenital, familial and genetic disorders     
Anomalous pulmonary venous connection  1  0/36 (0.00%)  0 1/33 (3.03%)  1
Atrial septal defect  1  1/36 (2.78%)  1 0/33 (0.00%)  0
Pterygium colli  1  0/36 (0.00%)  0 1/33 (3.03%)  1
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  1/36 (2.78%)  1 0/33 (0.00%)  0
Infections and infestations     
Cellulitis  1  0/36 (0.00%)  0 1/33 (3.03%)  1
Gastroenteritis  1  1/36 (2.78%)  1 0/33 (0.00%)  0
Lobar pneumonia  1  0/36 (0.00%)  0 1/33 (3.03%)  1
Pneumonia  1  0/36 (0.00%)  0 1/33 (3.03%)  1
Musculoskeletal and connective tissue disorders     
Scoliosis  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Medulloblastoma  1  1/36 (2.78%)  1 0/33 (0.00%)  0
Nervous system disorders     
Headache  1  1/36 (2.78%)  1 0/33 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Mediastinal mass  1  1/36 (2.78%)  1 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Treated Early Untreated
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/36 (94.44%)      32/33 (96.97%)    
Cardiac disorders     
Palpitations  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Ear and labyrinth disorders     
Conductive deafness  1  4/36 (11.11%)  4 1/33 (3.03%)  1
Ear pain  1  6/36 (16.67%)  8 3/33 (9.09%)  4
Hearing impaired  1  2/36 (5.56%)  2 3/33 (9.09%)  3
Tympanic membrane perforation  1  7/36 (19.44%)  8 2/33 (6.06%)  2
Endocrine disorders     
Autoimmune thyroiditis  1  0/36 (0.00%)  0 2/33 (6.06%)  2
Goitre  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Hypothyroidism  1  4/36 (11.11%)  4 5/33 (15.15%)  5
Eye disorders     
Myopia  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Gastrointestinal disorders     
Abdominal pain  1  4/36 (11.11%)  4 2/33 (6.06%)  2
Abdominal pain upper  1  1/36 (2.78%)  1 3/33 (9.09%)  3
Coeliac disease  1  1/36 (2.78%)  1 3/33 (9.09%)  3
Constipation  1  3/36 (8.33%)  3 2/33 (6.06%)  2
Diarrhoea  1  5/36 (13.89%)  5 5/33 (15.15%)  5
Gastrooesophageal reflux disease  1  2/36 (5.56%)  2 2/33 (6.06%)  2
Tooth malformation  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Toothache  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Vomiting  1  12/36 (33.33%)  12 3/33 (9.09%)  3
General disorders     
Pain  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Peripheral swelling  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Pyrexia  1  11/36 (30.56%)  11 8/33 (24.24%)  8
Immune system disorders     
Drug hypersensitivity  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Multiple allergies  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Seasonal allergy  1  5/36 (13.89%)  5 2/33 (6.06%)  2
Infections and infestations     
Bronchitis  1  5/36 (13.89%)  5 4/33 (12.12%)  4
Conjunctivitis  1  4/36 (11.11%)  4 3/33 (9.09%)  3
Croup infectious  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Ear infection  1  7/36 (19.44%)  7 2/33 (6.06%)  2
Eye infection  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Gastroenteritis viral  1  7/36 (19.44%)  7 4/33 (12.12%)  5
Impetigo  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Influenza  1  6/36 (16.67%)  6 3/33 (9.09%)  3
Kidney infection  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Mononucleosis syndrome  1  0/36 (0.00%)  0 2/33 (6.06%)  2
Nasopharyngitis  1  8/36 (22.22%)  9 4/33 (12.12%)  5
Otitis externa  1  3/36 (8.33%)  4 5/33 (15.15%)  6
Otitis media  1  9/36 (25.00%)  11 12/33 (36.36%)  14
Pharyngitis streptococcal  1  4/36 (11.11%)  4 9/33 (27.27%)  9
Pneumonia  1  2/36 (5.56%)  2 2/33 (6.06%)  2
Sinusitis  1  7/36 (19.44%)  7 7/33 (21.21%)  7
Upper respiratory tract infection  1  1/36 (2.78%)  1 6/33 (18.18%)  7
Urinary tract infection  1  8/36 (22.22%)  9 0/33 (0.00%)  0
Vaginal infection  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Viral infection  1  4/36 (11.11%)  5 0/33 (0.00%)  0
Injury, poisoning and procedural complications     
Joint dislocation  1  2/36 (5.56%)  2 2/33 (6.06%)  2
Ligament sprain  1  0/36 (0.00%)  0 2/33 (6.06%)  2
Radius fracture  1  3/36 (8.33%)  3 2/33 (6.06%)  2
Wrist fracture  1  0/36 (0.00%)  0 2/33 (6.06%)  2
Investigations     
Echocardiogram normal  1  2/36 (5.56%)  2 6/33 (18.18%)  6
Electrocardiogram normal  1  1/36 (2.78%)  1 2/33 (6.06%)  2
Ultrasound kidney normal  1  2/36 (5.56%)  2 2/33 (6.06%)  2
Ultrasound scan normal  1  0/36 (0.00%)  0 2/33 (6.06%)  2
Metabolism and nutrition disorders     
Hyperlipidaemia  1  3/36 (8.33%)  3 1/33 (3.03%)  1
Musculoskeletal and connective tissue disorders     
Kyphosis  1  5/36 (13.89%)  5 3/33 (9.09%)  3
Neck pain  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Scoliosis  1  7/36 (19.44%)  7 10/33 (30.30%)  10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Haemangioma  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Melanocytic naevus  1  11/36 (30.56%)  11 9/33 (27.27%)  9
Skin papilloma  1  6/36 (16.67%)  7 4/33 (12.12%)  4
Nervous system disorders     
Headache  1  11/36 (30.56%)  13 9/33 (27.27%)  10
Psychiatric disorders     
Anxiety  1  7/36 (19.44%)  7 6/33 (18.18%)  6
Depression  1  2/36 (5.56%)  2 3/33 (9.09%)  3
Insomnia  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Obsessive-compulsive disorder  1  2/36 (5.56%)  2 2/33 (6.06%)  2
Renal and urinary disorders     
Dysuria  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Enuresis  1  1/36 (2.78%)  1 2/33 (6.06%)  2
Reproductive system and breast disorders     
Dysmenorrhoea  1  3/36 (8.33%)  3 2/33 (6.06%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/36 (22.22%)  8 6/33 (18.18%)  6
Nasal congestion  1  1/36 (2.78%)  1 3/33 (9.09%)  3
Oropharyngeal pain  1  5/36 (13.89%)  5 4/33 (12.12%)  4
Respiratory disorder  1  1/36 (2.78%)  1 2/33 (6.06%)  2
Rhinorrhoea  1  2/36 (5.56%)  2 3/33 (9.09%)  3
Sinus congestion  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Skin and subcutaneous tissue disorders     
Acne  1  3/36 (8.33%)  3 0/33 (0.00%)  0
Eczema  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Keloid scar  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Rash  1  0/36 (0.00%)  0 5/33 (15.15%)  5
Seborrhoea  1  1/36 (2.78%)  1 3/33 (9.09%)  3
Seborrhoeic dermatitis  1  1/36 (2.78%)  1 3/33 (9.09%)  3
Social circumstances     
Corrective lens user  1  3/36 (8.33%)  3 8/33 (24.24%)  8
Orthodontic appliance user  1  9/36 (25.00%)  9 7/33 (21.21%)  7
Surgical and medical procedures     
Adenoidectomy  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Ear tube insertion  1  4/36 (11.11%)  5 5/33 (15.15%)  7
Mole excision  1  6/36 (16.67%)  6 2/33 (6.06%)  2
Oral surgery  1  2/36 (5.56%)  2 0/33 (0.00%)  0
Orthodontic procedure  1  4/36 (11.11%)  4 7/33 (21.21%)  7
Palatal operation  1  3/36 (8.33%)  3 0/33 (0.00%)  0
Tooth extraction  1  2/36 (5.56%)  2 2/33 (6.06%)  2
Tympanoplasty  1  5/36 (13.89%)  5 3/33 (9.09%)  3
Wisdom teeth removal  1  2/36 (5.56%)  2 1/33 (3.03%)  1
Vascular disorders     
Aortic dilatation  1  0/36 (0.00%)  0 3/33 (9.09%)  3
Hypertension  1  1/36 (2.78%)  1 2/33 (6.06%)  2
Lymphoedema  1  3/36 (8.33%)  3 1/33 (3.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00266656     History of Changes
Other Study ID Numbers: 10088
B9R-US-GDGH ( Other Identifier: Eli Lilly and Company )
First Submitted: December 15, 2005
First Posted: December 19, 2005
Results First Submitted: July 13, 2016
Results First Posted: August 23, 2016
Last Update Posted: March 31, 2017