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Trial record 1 of 1 for:    dge00105
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A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)

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: NCT00444626
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Facial Wrinkles at the Nasolabial Folds
Interventions Device: Dermal Gel Extra (DGE)
Device: Restylane
Drug: EMLA Cream
Enrollment 140
Recruitment Details  
Pre-assignment Details 166 subjects screened, 26 subjects were never randomized.
Arm/Group Title Combined Arm
Hide Arm/Group Description Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
Period Title: Initial Treatment Period
Started 140
Completed 128
Not Completed 12
Reason Not Completed
Withdrawal by Subject             2
Adverse Event             1
Lost to Follow-up             9
Period Title: Repeat Treatment Period
Started 105 [1]
Completed 105
Not Completed 0
[1]
23 subjects withdrew after completing the Initial Treatment and did not enter the Repeat Treatment
Arm/Group Title Combined Arms
Hide Arm/Group Description Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
Overall Number of Baseline Participants 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants
52.7  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants
Female
135
  96.4%
Male
5
   3.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants
American Indian or Alaskan Native 9
Asian 1
Black or African American 24
Native Hawaiian or Other Pacific Islander 2
White 100
Other 5
Not Available 3
[1]
Measure Description: Multiple responses were possible for race as the screening visit CRF stated “check all that apply”.
1.Primary Outcome
Title Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24
Hide Description

This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.

Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.
Arm/Group Title Dermal Gel Extra (DGE) Restylane
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Overall Number of Participants Analyzed 129 129
Overall Number of Units Analyzed
Type of Units Analyzed: Nasolabial folds
129 129
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.8  (1.0) 1.8  (1.1)
2.Secondary Outcome
Title Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)
Hide Description The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.
Arm/Group Title Dermal Gel Extra (DGE) Restylane
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Overall Number of Participants Analyzed 129 129
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0 time after injection 23.2  (20.3) 48.9  (26.0)
15 minutes after injection 6.1  (10.1) 16.3  (18.0)
30 minutes after injection 3.3  (7.0) 7.9  (13.0)
3.Secondary Outcome
Title Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36
Hide Description

Mean change between Baseline and the Week 36 score (Baseline minus week 36 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement.

Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.

Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.
Arm/Group Title Dermal Gel Extra (DGE) Restylane
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Overall Number of Participants Analyzed 127 127
Overall Number of Units Analyzed
Type of Units Analyzed: Nasolabial folds
127 127
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.3  (1.2) 1.3  (1.2)
4.Secondary Outcome
Title Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24
Hide Description Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.
Arm/Group Title Dermal Gel Extra (DGE) Restylane
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Overall Number of Participants Analyzed 129 129
Measure Type: Number
Unit of Measure: Participants
114 113
5.Secondary Outcome
Title Participant Product Preference at Week 24
Hide Description Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.
Arm/Group Title Dermal Gel Extra (DGE) Restylane
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Overall Number of Participants Analyzed 129 129
Measure Type: Number
Unit of Measure: Participants
56 68
6.Secondary Outcome
Title Participant Product Preference at Week 36
Hide Description Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.
Arm/Group Title Dermal Gel Extra (DGE) Restylane
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Overall Number of Participants Analyzed 129 129
Measure Type: Number
Unit of Measure: Participants
62 55
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period
Hide Description

Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure.

If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive.

Time Frame Weeks 1-36
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients randomized to initial treatment phase. Safety Population.
Arm/Group Title Dermal Gel Extra (DGE) Restylane Non-NLF
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
Adverse events that did not occur at the nasolabial folds
Overall Number of Participants Analyzed 140 140 140
Measure Type: Number
Unit of Measure: Participants
Patients with at least one Adverse Event (AE) 99 89 28
AEs by Severity - Mild 47 58 13
AEs by Severity - Moderate 37 24 10
AEs by Severity - Severe 15 7 5
AEs by Relationship - Procedure or Device 98 87 5
AEs by Relationship - Procedure Related 69 61 3
AEs by Relationship - Device Related 91 78 2
AEs by Duration - less than or equal to 7 days 70 67 5
AEs by Duration - more than 7 days 29 22 23
AEs by Treatment - No Treatment 54 57 6
AEs by Treatment - Medication 13 8 18
AEs by Treatment - Non-drug Therapy 32 24 3
AEs by Treatment - Hospitalization 0 0 1
Patients with Baseline AEs 0 0 0
Patients with Serious AEs 0 0 1
Patients with Study Discontinuation due to AEs 0 0 1
Number of Deaths 0 0 0
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period
Hide Description

Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure.

If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive.

Time Frame weeks 36 up to 47 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population for repeat treatment.
Arm/Group Title Dermal Gel Extra (DGE) Restylane - Dermal Gel Extra (DGE) Non-NLF
Hide Arm/Group Description:
Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. In the Repeat Treatment Period, participants received DGE on both sides of their face. This represents the experience with DGE for the side of the face that was originally treated with Restylane.
Adverse events that did not occur at the nasolabial folds
Overall Number of Participants Analyzed 105 105 105
Measure Type: Number
Unit of Measure: Participants
Patients with at least one Adverse Event (AE) 55 52 9
AEs by Severity - Mild 32 34 5
AEs by Severity - Moderate 19 15 2
AEs by Severity - Severe 4 3 2
AEs by Relationship - Procedure or Device (DGE) 54 50 2
AEs by Relationship - Procedure Related 50 46 2
AEs by Relationship - Device (DGE) Related 51 47 2
AEs by Duration - less than or equal to 7 days 44 44 7
AEs by Duration - more than 7 days 11 8 2
AEs by Treatment - No Treatment 41 40 3
AEs by Treatment - Medication 7 5 6
AEs by Treatment - Non-drug Therapy 7 7 0
AEs by Treatment - Hospitalization 0 0 0
Patients with a Serious AEs 0 0 1
Patients with Study Discontinuation due to AEs 0 0 0
Number of Deaths 0 0 0
Time Frame Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47)
Adverse Event Reporting Description Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
 
Arm/Group Title Dermal Gel Extra (DGE): Initial Treatment Period Restylane: Initial Treatment Period Non-NLF: Initial Treatment Period Dermal Gel Extra (DGE) - Repeat Treatment Period Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period Non-NLF: Repeat Treatment Period
Hide Arm/Group Description Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment. Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment. Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment. Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment. Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment. Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
All-Cause Mortality
Dermal Gel Extra (DGE): Initial Treatment Period Restylane: Initial Treatment Period Non-NLF: Initial Treatment Period Dermal Gel Extra (DGE) - Repeat Treatment Period Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period Non-NLF: Repeat Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Dermal Gel Extra (DGE): Initial Treatment Period Restylane: Initial Treatment Period Non-NLF: Initial Treatment Period Dermal Gel Extra (DGE) - Repeat Treatment Period Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period Non-NLF: Repeat Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/140 (0.00%)   0/140 (0.00%)   1/140 (0.71%)   0/105 (0.00%)   0/105 (0.00%)   1/105 (0.95%) 
Gastrointestinal disorders             
Gastric ulcer  1 [1]  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Colon cancer  1 [1]  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Reported by investigator as unrelated to study device.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dermal Gel Extra (DGE): Initial Treatment Period Restylane: Initial Treatment Period Non-NLF: Initial Treatment Period Dermal Gel Extra (DGE) - Repeat Treatment Period Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period Non-NLF: Repeat Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   99/140 (70.71%)   89/140 (63.57%)   28/140 (20.00%)   55/105 (52.38%)   52/105 (49.52%)   9/105 (8.57%) 
Blood and lymphatic system disorders             
Haemorrhagic anaemia  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Eye disorders             
Vitreous floaters  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Gastrointestinal disorders             
Hypoaesthesia oral  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Localised intraabdominal fluid collection  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Oral disorder  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Stomach discomfort  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Vomiting  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Duodenitis  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Gastritis  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Lip swelling  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Upper gastrointestinal haemorrhage  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
General disorders             
Injection site swelling  1  78/140 (55.71%)  69/140 (49.29%)  0/140 (0.00%)  47/105 (44.76%)  47/105 (44.76%)  0/105 (0.00%) 
Injection site pain  1  61/140 (43.57%)  57/140 (40.71%)  0/140 (0.00%)  34/105 (32.38%)  32/105 (30.48%)  0/105 (0.00%) 
Injection site bruising  1  35/140 (25.00%)  29/140 (20.71%)  0/140 (0.00%)  23/105 (21.90%)  23/105 (21.90%)  0/105 (0.00%) 
Injection site erythema  1  30/140 (21.43%)  27/140 (19.29%)  0/140 (0.00%)  33/105 (31.43%)  33/105 (31.43%)  0/105 (0.00%) 
Injection site nodule  1  12/140 (8.57%)  6/140 (4.29%)  0/140 (0.00%)  3/105 (2.86%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site pruritus  1  11/140 (7.86%)  8/140 (5.71%)  0/140 (0.00%)  6/105 (5.71%)  7/105 (6.67%)  0/105 (0.00%) 
Injection site anaesthesia  1  6/140 (4.29%)  1/140 (0.71%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site induration  1  2/140 (1.43%)  0/140 (0.00%)  0/140 (0.00%)  1/105 (0.95%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site paraesthesia  1  2/140 (1.43%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site discolouration  1  1/140 (0.71%)  1/140 (0.71%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site discomfort  1  1/140 (0.71%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site dryness  1  1/140 (0.71%)  1/140 (0.71%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site haemorrhage  1  1/140 (0.71%)  0/140 (0.00%)  0/140 (0.00%)  1/105 (0.95%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site inflammation  1  1/140 (0.71%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site papule  1  1/140 (0.71%)  1/140 (0.71%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Cyst  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Influenza like illness  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Pyrexia  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Immune system disorders             
Allergy to arthropod bite  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Seasonal allergy  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Infections and infestations             
Nasopharyngitis  1  0/140 (0.00%)  0/140 (0.00%)  4/140 (2.86%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Upper respiratory tract infection  1  0/140 (0.00%)  0/140 (0.00%)  3/140 (2.14%)  0/105 (0.00%)  0/105 (0.00%)  2/105 (1.90%) 
Bronchitis  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Gastroenteritis viral  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Herpes zoster  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Onychomycosis  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Pneumonia  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Viral infection  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Injection site pustule  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  1/105 (0.95%)  1/105 (0.95%)  0/105 (0.00%) 
Sinusitis  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Injury, poisoning and procedural complications             
Contusion  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Fall  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Foot fracture  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Open wound  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Post procedural diarrhoea  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Post procedural swelling  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Postoperative constipation  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Procedural nausea  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Procedural pain  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Investigations             
Bone density decreased  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Intraocular pressure increased  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Metabolism and nutrition disorders             
Hypercholesterolaemia  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  0/140 (0.00%)  0/140 (0.00%)  2/140 (1.43%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Neck pain  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Osteopenia  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Pain in extremity  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Pain in jaw  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Resorption bone increased  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Nervous system disorders             
Headache  1  0/140 (0.00%)  0/140 (0.00%)  3/140 (2.14%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Dizziness  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Sinus headache  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Reproductive system and breast disorders             
Menorrhagia  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Rhinorrhoea  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Sinus congestion  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Postnasal drip  1  0/140 (0.00%)  0/140 (0.00%)  0/140 (0.00%)  0/105 (0.00%)  0/105 (0.00%)  1/105 (0.95%) 
Skin and subcutaneous tissue disorders             
Blister  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Erythema  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Skin exfoliation  1  0/140 (0.00%)  0/140 (0.00%)  1/140 (0.71%)  0/105 (0.00%)  0/105 (0.00%)  0/105 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
Principal investigators (PI) will give Genzyme a draft manuscript or draft publication 60 days before publication. Genzyme will make every reasonable attempt to review publication or manuscript and give feedback in such 60 day period. PI will not use Genzyme confidential information without prior written consent.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Genzyme Medical Information (MedInfo)
Organization: Genzyme
EMail: medinfo@genzyme.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00444626    
Other Study ID Numbers: DGE00105
First Submitted: March 7, 2007
First Posted: March 8, 2007
Results First Submitted: April 7, 2015
Results First Posted: April 22, 2015
Last Update Posted: April 22, 2015