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Real World CCH Study in Adult Females With Cellulite

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: NCT04170296
Recruitment Status : Completed
First Posted : November 20, 2019
Results First Posted : February 22, 2022
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Edematous Fibrosclerotic Panniculopathy (EFP)
Cellulite
Intervention Drug: EN3835
Enrollment 153
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Posterolateral Thigh Cohort 2: Buttocks
Hide Arm/Group Description

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Period Title: Overall Study
Started 81 72
Completed 73 68
Not Completed 8 4
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             3             2
Lost to Follow-up             4             2
Arm/Group Title Cohort 1: Posterolateral Thigh Cohort 2: Buttocks Total
Hide Arm/Group Description

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

 Total of all reporting groups
Overall Number of Baseline Participants 81 72 153
Hide Baseline Analysis Population Description
Safety Population includes all participants who have at least 1 injection of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 72 participants 153 participants
43.2  (9.40) 42.7  (9.35) 43.0  (9.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 72 participants 153 participants
Female
81
 100.0%
72
 100.0%
153
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 72 participants 153 participants
Hispanic or Latino
10
  12.3%
18
  25.0%
28
  18.3%
Not Hispanic or Latino
71
  87.7%
54
  75.0%
125
  81.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 72 participants 153 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.5%
2
   2.8%
4
   2.6%
Native Hawaiian or Other Pacific Islander
1
   1.2%
0
   0.0%
1
   0.7%
Black or African American
2
   2.5%
2
   2.8%
4
   2.6%
White
74
  91.4%
65
  90.3%
139
  90.8%
More than one race
0
   0.0%
1
   1.4%
1
   0.7%
Unknown or Not Reported
2
   2.5%
2
   2.8%
4
   2.6%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 81 participants 72 participants 153 participants
65.082  (8.3341) 65.042  (8.9403) 65.063  (8.5961)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 81 participants 72 participants 153 participants
164.548  (6.2671) 165.192  (6.6315) 164.851  (6.4279)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 81 participants 72 participants 153 participants
24.03  (2.640) 23.89  (2.759) 23.96  (2.689)
Skin Category (Fitzpatrick Scale)  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 81 participants 72 participants 153 participants
I (Pale White)
2
   2.5%
1
   1.4%
3
   2.0%
II (Fair)
33
  40.7%
24
  33.3%
57
  37.3%
III (Darker White)
24
  29.6%
28
  38.9%
52
  34.0%
IV (Light Brown)
18
  22.2%
14
  19.4%
32
  20.9%
V (Brown)
4
   4.9%
4
   5.6%
8
   5.2%
VI (Dark Brown or Black)
0
   0.0%
1
   1.4%
1
   0.7%
1.Primary Outcome
Title The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Posterolateral Thigh
Hide Description Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation
Arm/Group Title Cohort 1: Posterolateral Thigh
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
58
  92.1%
2.Primary Outcome
Title The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Hide Description Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population includes all participants who have at least 1 injection of study medication and have at least 1 I-GAIS evaluation
Arm/Group Title Cohort 2: Buttocks
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
58
  95.1%
3.Secondary Outcome
Title Mean Change From Baseline in CR-PCSS for Each Buttock
Hide Description Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) is a 5-point photonumeric scale rating cellulite severity from "0" (none) to "4" (severe) from a clinician's perspective.
Time Frame Day 22, 43, 90 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation. Number of participants analyzed are evaluable population participants that had a change from baseline at the specified visit
Arm/Group Title Cohort 2: Buttocks (Left) Cohort 2: Buttocks (Right)
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 71 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 22 Number Analyzed 69 participants 69 participants
-0.3  (0.52) -0.3  (0.50)
Day 43 Number Analyzed 67 participants 67 participants
-0.6  (0.63) -0.5  (0.59)
Day 90 Number Analyzed 61 participants 61 participants
-0.7  (0.70) -0.7  (0.53)
Day 180 Number Analyzed 66 participants 66 participants
-0.7  (0.63) -0.6  (0.63)
4.Secondary Outcome
Title Mean Change From Baseline in Body Q Appraisal of Cellulite for Posterolateral Thigh Based on Total Score
Hide Description The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Time Frame Day 90, Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
Arm/Group Title Cohort 1: Posterolateral Thigh
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 90 Number Analyzed 63 participants
10.9  (9.84)
Day 180 Number Analyzed 68 participants
10.9  (9.76)
5.Secondary Outcome
Title Mean Change From Baseline in Body Q Appraisal of Cellulite for Buttock Based on Total Score
Hide Description The Body-Q Appraisal of Cellulite is a subset of questions from the Body-Q questionnaire developed to measure participant perceptions of weight loss and/or body contouring. The minimum possible score is 11 and the maximum possible score is 44. Higher scores indicate the individual is less bothered by their cellulite. Copyright Memorial Sloan-Kettering Cancer Center
Time Frame Day 90, Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
Arm/Group Title Cohort 2: Buttocks
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 71
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 90 Number Analyzed 61 participants
8.8  (8.38)
Day 180 Number Analyzed 66 participants
8.8  (9.57)
6.Secondary Outcome
Title The Proportion of Participants With Improved (+1 or Better) Score on I GAIS for Either Posterolateral Thigh
Hide Description Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time Frame Day 22, 43, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Population includes all participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation.
Arm/Group Title Cohort 1: Posterolateral Thigh
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 76
Measure Type: Count of Participants
Unit of Measure: Participants
Day 22 Number Analyzed 70 participants
64
  91.4%
Day 43 Number Analyzed 67 participants
59
  88.1%
Day 180 Number Analyzed 68 participants
61
  89.7%
7.Secondary Outcome
Title The Proportion of Participants With Improved (+1 or Better) Score on I-GAIS for Either Buttock
Hide Description Investigator Global Aesthetic Improvement Scale (I-GAIS) is a 7-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator. The rating categories are "Very Much Worse", "Much Worse", "Worse", "No Change", "Improved", "Much Improved", and "Very Much Improved".
Time Frame Day 22, 43, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population includes all Participants who received at least 1 injection of study medication and had at least 1 I-GAIS evaluation
Arm/Group Title Cohort 2: Buttocks
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
Day 22 Number Analyzed 69 participants
50
  72.5%
Day 43 Number Analyzed 67 participants
62
  92.5%
Day 180 Number Analyzed 66 participants
59
  89.4%
8.Secondary Outcome
Title Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Posterolateral Thigh)
Hide Description Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time Frame Day 1, 90, and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received at least 1 injection of study medication
Arm/Group Title Cohort 1: Posterolateral Thigh (Anti AUX-I) Cohort 1: Posterolateral Thigh (Anti AUX-II)
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 81 81
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 81 participants 81 participants
5
   6.2%
5
   6.2%
Day 90 Number Analyzed 60 participants 60 participants
60
 100.0%
60
 100.0%
Day 180 Number Analyzed 68 participants 68 participants
68
 100.0%
68
 100.0%
9.Secondary Outcome
Title Percentage of Participants With Positive Antibody Titers for Anti-AUX-I and Anti AUX-II (Buttocks)
Hide Description Immunogenicity samples with a positive titer value will undergo a log transformation for analyses. Samples with titer level less than 10 were assigned or imputed as a log transformed titer of 1 for analyses
Time Frame Day 1, 90 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all participants who received at least 1 injection of study medication
Arm/Group Title Cohort 2: Buttocks (Anti AUX-I) Cohort 2: Buttocks (Anti AUX-II)
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 72 72
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 72 participants 72 participants
7
   9.7%
5
   6.9%
Day 90 Number Analyzed 61 participants 61 participants
61
 100.0%
61
 100.0%
Day 180 Number Analyzed 66 participants 66 participants
66
 100.0%
65
  98.5%
10.Secondary Outcome
Title Presence of Neutralizing Antibody (NAb) Anti AUX-I and AUX-II (Posterolateral Thigh)
Hide Description All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time Frame Day 1, 90 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit.
Arm/Group Title Cohort 1: Posterolateral Thigh (Anti AUX-I) Cohort 1: Posterolateral Thigh (Anti AUX-II)
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 13 17
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 2 participants 1 participants
Positive
1
  50.0%
0
   0.0%
Negative
1
  50.0%
1
 100.0%
Day 90 Number Analyzed 13 participants 17 participants
Positive
13
 100.0%
16
  94.1%
Negative
0
   0.0%
1
   5.9%
Day 180 Number Analyzed 11 participants 15 participants
Positive
8
  72.7%
12
  80.0%
Negative
3
  27.3%
3
  20.0%
11.Secondary Outcome
Title Presence of NAb Anti AUX-I and AUX-II (Buttocks)
Hide Description All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb.
Time Frame Day 1, 90 and 180
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Safety Population samples were analyzed for NAbs. All the samples with positive ADAs for the participants who had had every other titer levels in the first quartile and fourth quartile of all positive ADAs at Day 90 (performed separately for AUX-I and AUX-II) were tested for NAb. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the assessment. Percentages are based on number of participants tested for NAb at the visit.
Arm/Group Title Cohort 2: Buttocks (Anti AUX-I) Cohort 2: Buttocks (Anti AUX-II)
Hide Arm/Group Description:

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
Overall Number of Participants Analyzed 17 13
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 2 participants 2 participants
Positive
2
 100.0%
2
 100.0%
Negative
0
   0.0%
0
   0.0%
Day 90 Number Analyzed 17 participants 13 participants
Positive
15
  88.2%
9
  69.2%
Negative
2
  11.8%
4
  30.8%
Day 180 Number Analyzed 17 participants 13 participants
Positive
15
  88.2%
9
  69.2%
Negative
2
  11.8%
4
  30.8%
Time Frame Time of informed consent signature until Day 180
Adverse Event Reporting Description All serious and non-serious AEs, whether elicited or observed during study visit or spontaneously reported by the participant, including events that occurred from the time the participant signed the study specific consent form until completion of or discharge from the study
 
Arm/Group Title Cohort 1: Posterolateral Thigh Cohort 2: Buttocks
Hide Arm/Group Description

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)

EN3835 up to 1.68mg (Collagenase Clostridium Histolyticum)

EN3835: Collagenase Clostridium Histolyticum (CCH)
All-Cause Mortality
Cohort 1: Posterolateral Thigh Cohort 2: Buttocks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)      0/72 (0.00%)    
Hide Serious Adverse Events
Cohort 1: Posterolateral Thigh Cohort 2: Buttocks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      0/72 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cohort 1: Posterolateral Thigh Cohort 2: Buttocks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   75/81 (92.59%)      69/72 (95.83%)    
General disorders     
Injection site bruising † 1  70/81 (86.42%)  311 67/72 (93.06%)  327
Injection site dermatitis † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
Injection site discolouration † 1  14/81 (17.28%)  32 24/72 (33.33%)  46
Injection site erythema † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Injection site haemorrhage † 1  3/81 (3.70%)  18 2/72 (2.78%)  12
Injection site mass † 1  4/81 (4.94%)  7 5/72 (6.94%)  10
Injection site nodule † 1  7/81 (8.64%)  17 5/72 (6.94%)  14
Injection site oedema † 1  8/81 (9.88%)  34 5/72 (6.94%)  22
Injection site pain † 1  53/81 (65.43%)  244 57/72 (79.17%)  298
Injection site pruritus † 1  10/81 (12.35%)  37 14/72 (19.44%)  35
Injection site rash † 1  1/81 (1.23%)  2 0/72 (0.00%)  0
Injection site reaction † 1  2/81 (2.47%)  3 0/72 (0.00%)  0
Injection site swelling † 1  12/81 (14.81%)  32 13/72 (18.06%)  34
Injection site warmth † 1  1/81 (1.23%)  2 0/72 (0.00%)  0
Pyrexia † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
Immune system disorders     
Drug hypersensitivity † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Infections and infestations     
Nasopharyngitis † 1  2/81 (2.47%)  3 0/72 (0.00%)  0
Oral herpes † 1  1/81 (1.23%)  2 0/72 (0.00%)  0
Sinusitis † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Urinary tract infection † 1  2/81 (2.47%)  2 1/72 (1.39%)  1
Injury, poisoning and procedural complications     
Thermal burn † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Investigations     
Alanine aminotransferase increased † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Aspartate aminotransferase increased † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Blood potassium increased † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
Blood sodium increased † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Blood urine present † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Coronavirus test positive † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
Hepatic enzyme increased † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Nitrite urine present † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
Urine ketone body present † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Urine leukocyte esterase positive † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
White blood cell count increased † 1  1/81 (1.23%)  1 1/72 (1.39%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Nervous system disorders     
Dizziness † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Migraine † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Psychiatric disorders     
Anxiety † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
Skin and subcutaneous tissue disorders     
Diffuse alopecia † 1  0/81 (0.00%)  0 1/72 (1.39%)  1
Post-inflammatory pigmentation change † 1  5/81 (6.17%)  10 2/72 (2.78%)  4
Vascular disorders     
Hypertension † 1  1/81 (1.23%)  1 0/72 (0.00%)  0
1
Term from vocabulary, MedDRA 22.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: David Hernandez, MD
Organization: Endo Pharmaceuticals
Phone: 800-462-3636
EMail: clinicaltrials@endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04170296    
Other Study ID Numbers: EN3835-305
First Submitted: November 18, 2019
First Posted: November 20, 2019
Results First Submitted: October 6, 2021
Results First Posted: February 22, 2022
Last Update Posted: February 22, 2022