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Long-term Open-Label Safety Study to Evaluate EN3409

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ClinicalTrials.gov Identifier: NCT01755546
Recruitment Status : Completed
First Posted : December 24, 2012
Results First Posted : September 12, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Low Back Pain
Osteoarthritis
Neuropathic Pain
Intervention Drug: EN3409
Enrollment 304
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Overall
Hide Arm/Group Description All subjects combined, Roll Over and De Novo.
Period Title: Screened and Taper (Rollover and DeNovo)
Started 304
Completed 294
Not Completed 10
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             3
Lost to Follow-up             1
Any other reason and screen failures             5
Period Title: Titration Phase
Started 294
Completed 224
Not Completed 70
Reason Not Completed
Adverse Event             11
Lack of Efficacy             18
Protocol Violation             9
Lost to Follow-up             2
Other and Continuing             22
Withdrawal by Subject             8
Period Title: Long Term Treatment
Started 224
Completed 103
Not Completed 121
Reason Not Completed
Adverse Event             12
Lack of Efficacy             6
Protocol Violation             10
Withdrawal by Subject             35
Lost to Follow-up             17
other and ongoing             41
Arm/Group Title Overall
Hide Arm/Group Description All subjects combined, Roll Over and De-Novo.
Overall Number of Baseline Participants 224
Hide Baseline Analysis Population Description
Baseline at start of Long-Term Treatment Phase
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants
<=18 years
0
   0.0%
Between 18 and 65 years
193
  86.2%
>=65 years
31
  13.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 224 participants
52  (11.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants
Female
125
  55.8%
Male
99
  44.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants
Hispanic or Latino
39
  17.4%
Not Hispanic or Latino
185
  82.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants
American Indian or Alaska Native
3
   1.3%
Asian
6
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
57
  25.4%
White
158
  70.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 224 participants
92.2  (21.57)
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 224 participants
169.5  (10.39)
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 224 participants
32.1  (7.20)
NRS Pain Intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 224 participants
3  (1.30)
[1]
Measure Description: The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used as baseline.
Chronic Pain  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants
Lower Back Pain
222
  99.1%
Neuropathic Pain
1
   0.4%
Osteoarthritis
1
   0.4%
1.Primary Outcome
Title Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
Hide Description The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Population
Arm/Group Title Overall
Hide Arm/Group Description:
All subjects combined, Roll Over and De-Novo.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (1.78)
Time Frame 48 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall
Hide Arm/Group Description All subjects combined, Roll Over and De-Novo.
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Overall
Affected / at Risk (%) # Events
Total   12/224 (5.36%)    
Gastrointestinal disorders   
Vomiting  1  1/224 (0.45%)  1
General disorders   
Influenza like illness  1  1/224 (0.45%)  1
Infections and infestations   
Bronchitis  1  1/224 (0.45%)  1
Cellulitis  1  1/224 (0.45%)  1
Sepsis  1  1/224 (0.45%)  1
Urosepsis  1  1/224 (0.45%)  1
Injury, poisoning and procedural complications   
Ankle Fracture  1  1/224 (0.45%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer  1  1/224 (0.45%)  1
Pancreatic carcinoma  1  1/224 (0.45%)  1
Nervous system disorders   
Syncope  1  1/224 (0.45%)  1
Status migrainosus  1  1/224 (0.45%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/224 (0.45%)  1
Renal impairment  1  1/224 (0.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Overall
Affected / at Risk (%) # Events
Total   115/224 (51.34%)    
Gastrointestinal disorders   
Nausea  1  18/224 (8.04%)  18
Vomiting  1  11/224 (4.91%)  11
Diarrhea  1  10/224 (4.46%)  10
Constipation  1  9/224 (4.02%)  9
Infections and infestations   
Upper respiratory tract infection  1  14/224 (6.25%)  14
Bronchitis  1  9/224 (4.02%)  9
Nasopharyngitis  1  7/224 (3.13%)  7
Injury, poisoning and procedural complications   
Fall  1  7/224 (3.13%)  7
Musculoskeletal and connective tissue disorders   
Back pain  1  13/224 (5.80%)  13
Nervous system disorders   
Headache  1  12/224 (5.36%)  12
Psychiatric disorders   
Depression  1  8/224 (3.57%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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: Vice President, Operations
Organization: BIODELIVERY
Phone: 919-582-0294
EMail: twarneke@bdsi.com
Layout table for additonal information
Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT01755546    
Other Study ID Numbers: EN3409-309
First Submitted: December 19, 2012
First Posted: December 24, 2012
Results First Submitted: March 16, 2018
Results First Posted: September 12, 2018
Last Update Posted: October 18, 2018