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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Overall
Arm/Group Description	All subjects combined, Roll Over an...
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

Baseline Characteristics

Arm/Group Title		Overall
Arm/Group Description		All subjects combined, Roll Over an...
Arm/Group Description		All subjects combined, Roll Over and De-Novo.
Overall Number of Baseline Participants		224
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
Description	The NRS Pain intensity score is a segmented version of a visual analog...
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

Outcome Measure Data

Analysis Population Description

Efficacy Population


Arm/Group Title	Overall
Arm/Group Description:	All subjects combined, Roll Over an...
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)

Adverse Events

Time Frame	48 Weeks
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Overall
Arm/Group Description	All subjects combined, Roll Over an...
Arm/Group Description	All subjects combined, Roll Over and De-Novo.
All-Cause Mortality
	Overall
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

More Information

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

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