Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
Sponsor
Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Completed
CT.gov ID
NCT00256126
Collaborator
(none)
318
13
2
28
24.5
0.9
Study Details
Study Description
Brief Summary
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
318 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®
Actual Study Start Date
:
May 31, 2005
Actual Primary Completion Date
:
Sep 30, 2007
Actual Study Completion Date
:
Sep 30, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Turner Syndrome (TS)
|
Drug: Saizen
Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month
|
| Experimental: Growth Hormone Deficiency (GHD)
|
Drug: Saizen
Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1 [Baseline, Month 1]
IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing.
Secondary Outcome Measures
- Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1 [Baseline, Month 1]
- Change From Baseline in Fasting Glucose Levels at Month 1 [Baseline, Month 1]
- Change From Baseline in Fasting Insulin Levels at Month 1 [Baseline, Month 1]
- Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1 [Baseline, Month 1]
HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.
- Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1 [Baseline, Month 1]
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- One of the following diagnoses and candidacy for SAIZEN® therapy:
-
GHD: documented pre-established diagnosis of GHD with a growth hormone (GH) peak response of <10 microgram per liter (mcg/L) with 2 GH stimulation tests, without priming with oestradiol.
-
Turner syndrome: documented pre-established diagnosis by karyotype.
-
Prepubertal status according to Tanner Pre-established history of normal thyroid function or adequate substitution for at least 3 months.
-
Weight for stature within the population specific normal range (>5th and <95th percentiles) for gender Willingness and ability to comply with the protocol for the duration of the study.
-
Parent's or guardian's written informed consent, given before any study related procedure that is not part of the subject's normal medical care, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given.
Exclusion Criteria:
-
Acquired GHD due to central nervous system tumour, trauma, infection, infiltration (documented by imaging), and history of irradiation or cranial surgery
-
Previous treatment with GH, growth hormone-releasing hormone (GHRH), anabolic steroids or any treatment affecting growth.
-
Previous treatment with corticosteroids, except in case of topical or inhaled corticosteroid administration for atopic disease. Corticosteroids for hormonal substitution are also allowed if the condition and the treatment regimen have been stable for at least 3 months.
-
Severe associated pathology affecting growth such as malnutrition, malabsorption, or bone dysplasia.
-
Chronic severe kidney disease.
-
Chronic severe liver disease.
-
Chronic infectious disease.
-
Acute or severe illness during the previous 6 months.
-
Significant concomitant illness that would interfere with participation or assessment in this study.
-
Active malignancy (except non-melanomatous skin malignancies that have undergone surgical excision and/or biopsy, diagnosis and treatment to resolution)
-
History or active Idiopathic intra-cranial hypertension (benign intracranial hypertension or pseudo-tumor cerebri).
-
Diabetes Mellitus type I & II.
-
Any autoimmune disease.
-
Previous screening failure in this study.
-
Use of an investigational drug or participation in another clinical study within the last three months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Medical Information Office | Buenos Aires | Argentina | ||
| 2 | Local Medical Information Office | Sydney | Australia | ||
| 3 | Local Medical Information Office | Vienna | Austria | ||
| 4 | Local Medical Information Office | Mississauga | Canada | ||
| 5 | Local Medical InformationOffice | Paris | France | ||
| 6 | Local Medical Information Office | Munich | Germany | ||
| 7 | Local Medical Information Office | Rome | Italy | ||
| 8 | Local Medical Information Office | Oslo | Norway | ||
| 9 | Local Medical Information Office | Russia | Russian Federation | ||
| 10 | Local Medical Information Office | Singapore | Singapore | ||
| 11 | Local Medical Information Office | Madrid | Spain | ||
| 12 | Local Medical Information Office | Stockholm | Sweden | ||
| 13 | Local Medical Information Office | Feltham | United Kingdom |
Sponsors and Collaborators
- Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:
NCT00256126
Other Study ID Numbers:
- 24531
First Posted:
Nov 21, 2005
Last Update Posted:
Jun 26, 2018
Last Verified:
Mar 1, 2018
Study Results
Participant Flow
| Recruitment Details | First informed consent date: May 2005. Clinical data cutoff date: Oct 2007, Study completion date: Sep 2007. |
|---|---|
| Pre-assignment Detail | A total of 319 subjects were screened for this trial. Only 1 subject withdrew from the study prior to receiving the treatment due to personal reasons. Overall, 318 subjects were enrolled into the study. |
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) |
|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. |
| Period Title: Overall Study | ||
| STARTED | 149 | 169 |
| COMPLETED | 147 | 167 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) | Total |
|---|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. | Total of all reporting groups |
| Overall Participants | 149 | 169 | 318 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
9.3
(4.08)
|
8.94
(3.17)
|
9.11
(3.62)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
149
100%
|
63
37.3%
|
212
66.7%
|
| Male |
0
0%
|
106
62.7%
|
106
33.3%
|
Outcome Measures
| Title | Change From Baseline in Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) at Month 1 |
|---|---|
| Description | IGF-1 SDS was calculated using the Elmlinger reference method. Change in within subject IGF-1 levels (standard deviation scores) at Month 1 from Baseline was assessed. Descriptive statistics were determined for the Baseline and Month 1 assessments, and also for the level of change between these two assessments. If either the Baseline or Month 1 IGF-1 level was missing, then the within-subject change in IGF-1 was assumed to be missing. |
| Time Frame | Baseline, Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intention to Treat (ITT) population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure. |
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) |
|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. |
| Measure Participants | 143 | 162 |
| Mean (Standard Deviation) [Standard deviation score (SDS)] |
1.7692
(1.1889)
|
1.4007
(0.9811)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Turner Syndrome (TS), Growth Hormone Deficiency (GHD) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Change From Baseline in Insulin-like Growth Factor Binding Protein - 3 (IGFBP-3) Level at Month 1 |
|---|---|
| Description | |
| Time Frame | Baseline, Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure. |
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) |
|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. |
| Measure Participants | 143 | 162 |
| Mean (Standard Deviation) [milligram per liter (mg/L)] |
0.86
(0.96)
|
0.69
(0.81)
|
| Title | Change From Baseline in Fasting Glucose Levels at Month 1 |
|---|---|
| Description | |
| Time Frame | Baseline, Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure. |
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) |
|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. |
| Measure Participants | 122 | 142 |
| Mean (Standard Deviation) [millimoles per liter (mmol/L)] |
0.22
(0.8)
|
0.13
(0.65)
|
| Title | Change From Baseline in Fasting Insulin Levels at Month 1 |
|---|---|
| Description | |
| Time Frame | Baseline, Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure. |
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) |
|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. |
| Measure Participants | 142 | 160 |
| Mean (Standard Deviation) [picomole per liter (pmol/L)] |
47.7
(177.2)
|
26.9
(79.8)
|
| Title | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Month 1 |
|---|---|
| Description | HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5. |
| Time Frame | Baseline, Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure. |
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) |
|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. |
| Measure Participants | 120 | 136 |
| Mean (Standard Deviation) [picomole per liter *millimole per liter] |
2.132
(10.296)
|
1.061
(3.885)
|
| Title | Change From Baseline in Bone Alkaline Phosphatase Levels at Month 1 |
|---|---|
| Description | |
| Time Frame | Baseline, Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT population included all subjects who received at least 1 dose of study medication. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome measure. |
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) |
|---|---|---|
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. |
| Measure Participants | 144 | 162 |
| Mean (Standard Deviation) [Units per liter (U/L)] |
21.13
(80.68)
|
14.78
(25.23)
|
Adverse Events
| Time Frame | Adverse events were captured from first dose until at least 4 weeks following the last SAIZEN® administration or the post-treatment visit, whichever represented the longer period (up to a maximum of 2 months). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) | ||
| Arm/Group Description | Subjects with TS were administered with SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month. | Subjects with GHD were administered with SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month. | ||
All Cause Mortality |
||||
| Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/149 (0%) | 1/169 (0.6%) | ||
| Infections and infestations | ||||
| Tonsillitis streptococcal | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Turner Syndrome (TS) | Growth Hormone Deficiency (GHD) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/149 (24.2%) | 51/169 (30.2%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 1/149 (0.7%) | 1 | 1/169 (0.6%) | 1 |
| Ear pain | 1/149 (0.7%) | 1 | 0/169 (0%) | 0 |
| Endocrine disorders | ||||
| Precocious puberty | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Eye disorders | ||||
| Conjunctivitis allergic | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Gastrointestinal disorders | ||||
| Vomiting | 3/149 (2%) | 3 | 4/169 (2.4%) | 4 |
| Diarrhoea | 1/149 (0.7%) | 1 | 3/169 (1.8%) | 3 |
| Abdominal pain | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Constipation | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Enteritis | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Flatulence | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| General disorders | ||||
| Pyrexia | 6/149 (4%) | 7 | 9/169 (5.3%) | 9 |
| Injection site haemorrhage | 1/149 (0.7%) | 1 | 1/169 (0.6%) | 1 |
| Injection site irritation | 0/149 (0%) | 0 | 1/169 (0.6%) | 2 |
| Fatigue | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Influenza like illness | 1/149 (0.7%) | 1 | 0/169 (0%) | 0 |
| Injection site anaesthesia | 1/149 (0.7%) | 1 | 0/169 (0%) | 0 |
| Immune system disorders | ||||
| Seasonal allergy | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Infections and infestations | ||||
| Nasopharyngitis | 4/149 (2.7%) | 4 | 2/169 (1.2%) | 2 |
| Upper respiratory tract infection | 3/149 (2%) | 4 | 2/169 (1.2%) | 2 |
| Gastroenteritis | 1/149 (0.7%) | 2 | 2/169 (1.2%) | 2 |
| Ear infection | 2/149 (1.3%) | 2 | 0/169 (0%) | 0 |
| Influenza | 1/149 (0.7%) | 1 | 1/169 (0.6%) | 1 |
| Pharyngitis | 0/149 (0%) | 0 | 2/169 (1.2%) | 2 |
| Tonsillitis | 1/149 (0.7%) | 1 | 1/169 (0.6%) | 1 |
| Bronchitis | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Bronchitis acute | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Conjunctivitis viral | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Enterocolitis infectious | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Otitis externa | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Skin infection | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Urinary tract infection | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Investigations | ||||
| Blood thyroid stimulating hormone increased | 0/149 (0%) | 0 | 1/169 (0.6%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 0/149 (0%) | 0 | 1/169 (0.6%) | 2 |
| Back pain | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Bone pain | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Myalgia | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Pain in extremity | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Nervous system disorders | ||||
| Headache | 8/149 (5.4%) | 10 | 12/169 (7.1%) | 18 |
| Dizziness | 2/149 (1.3%) | 3 | 1/169 (0.6%) | 2 |
| Somnolence | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Psychiatric disorders | ||||
| Affect lability | 1/149 (0.7%) | 1 | 0/169 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 5/149 (3.4%) | 7 | 2/169 (1.2%) | 2 |
| Productive cough | 3/149 (2%) | 5 | 0/169 (0%) | 0 |
| Pharyngolaryngeal pain | 1/149 (0.7%) | 1 | 1/169 (0.6%) | 1 |
| Epistaxis | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Nasal congestion | 1/149 (0.7%) | 1 | 0/169 (0%) | 0 |
| Rhinitis allergic | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Throat irritation | 1/149 (0.7%) | 1 | 0/169 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Dermatitis atopic | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
| Urticaria | 0/149 (0%) | 0 | 1/169 (0.6%) | 1 |
Limitations/Caveats
Limitations of the trial were short duration of the study treatment, and relatively small sample size
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Merck KGaA Communication Center |
|---|---|
| Organization | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany |
| Phone | +49-6151-72-5200 |
| service@merckgroup.com |
Responsible Party:
Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:
NCT00256126
Other Study ID Numbers:
- 24531
First Posted:
Nov 21, 2005
Last Update Posted:
Jun 26, 2018
Last Verified:
Mar 1, 2018