Trial Outcomes & Findings for Long-term Open-Label Safety Study to Evaluate EN3409 (NCT NCT01755546)
NCT ID: NCT01755546
Last Updated: 2018-10-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
48 weeks
Results posted on
2018-10-18
Participant Flow
Participant milestones
| Measure |
Overall
All subjects combined, Roll Over and De Novo.
|
|---|---|
|
Screened and Taper (Rollover and DeNovo)
STARTED
|
304
|
|
Screened and Taper (Rollover and DeNovo)
COMPLETED
|
294
|
|
Screened and Taper (Rollover and DeNovo)
NOT COMPLETED
|
10
|
|
Titration Phase
STARTED
|
294
|
|
Titration Phase
COMPLETED
|
224
|
|
Titration Phase
NOT COMPLETED
|
70
|
|
Long Term Treatment
STARTED
|
224
|
|
Long Term Treatment
COMPLETED
|
103
|
|
Long Term Treatment
NOT COMPLETED
|
121
|
Reasons for withdrawal
| Measure |
Overall
All subjects combined, Roll Over and De Novo.
|
|---|---|
|
Screened and Taper (Rollover and DeNovo)
Protocol Violation
|
1
|
|
Screened and Taper (Rollover and DeNovo)
Withdrawal by Subject
|
3
|
|
Screened and Taper (Rollover and DeNovo)
Lost to Follow-up
|
1
|
|
Screened and Taper (Rollover and DeNovo)
Any other reason and screen failures
|
5
|
|
Titration Phase
Adverse Event
|
11
|
|
Titration Phase
Lack of Efficacy
|
18
|
|
Titration Phase
Protocol Violation
|
9
|
|
Titration Phase
Lost to Follow-up
|
2
|
|
Titration Phase
Other and Continuing
|
22
|
|
Titration Phase
Withdrawal by Subject
|
8
|
|
Long Term Treatment
Adverse Event
|
12
|
|
Long Term Treatment
Lack of Efficacy
|
6
|
|
Long Term Treatment
Protocol Violation
|
10
|
|
Long Term Treatment
Withdrawal by Subject
|
35
|
|
Long Term Treatment
Lost to Follow-up
|
17
|
|
Long Term Treatment
other and ongoing
|
41
|
Baseline Characteristics
Long-term Open-Label Safety Study to Evaluate EN3409
Baseline characteristics by cohort
| Measure |
Overall
n=224 Participants
All subjects combined, Roll Over and De-Novo.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
193 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
52 Years
STANDARD_DEVIATION 11.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
158 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight (kg)
|
92.2 kilograms
STANDARD_DEVIATION 21.57 • n=5 Participants
|
|
Height (cm)
|
169.5 centimeters
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
BMI (kg/m^2)
|
32.1 kg/m^2
STANDARD_DEVIATION 7.20 • n=5 Participants
|
|
NRS Pain Intensity
|
3 units on a scale
STANDARD_DEVIATION 1.30 • n=5 Participants
|
|
Chronic Pain
Lower Back Pain
|
222 Participants
n=5 Participants
|
|
Chronic Pain
Neuropathic Pain
|
1 Participants
n=5 Participants
|
|
Chronic Pain
Osteoarthritis
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Efficacy Population
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.
Outcome measures
| Measure |
Overall
n=97 Participants
All subjects combined, Roll Over and De-Novo.
|
|---|---|
|
Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
|
0.2 units on a scale
Standard Deviation 1.78
|
Adverse Events
Overall
Serious events: 12 serious events
Other events: 115 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall
n=224 participants at risk
All subjects combined, Roll Over and De-Novo.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
Cellulitis
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
Sepsis
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
Urosepsis
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Nervous system disorders
Syncope
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Nervous system disorders
Status migrainosus
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
General disorders
Influenza like illness
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.45%
1/224 • Number of events 1 • 48 Weeks
|
Other adverse events
| Measure |
Overall
n=224 participants at risk
All subjects combined, Roll Over and De-Novo.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
14/224 • Number of events 14 • 48 Weeks
|
|
Infections and infestations
Bronchitis
|
4.0%
9/224 • Number of events 9 • 48 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
7/224 • Number of events 7 • 48 Weeks
|
|
Gastrointestinal disorders
Nausea
|
8.0%
18/224 • Number of events 18 • 48 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
11/224 • Number of events 11 • 48 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
10/224 • Number of events 10 • 48 Weeks
|
|
Gastrointestinal disorders
Constipation
|
4.0%
9/224 • Number of events 9 • 48 Weeks
|
|
Nervous system disorders
Headache
|
5.4%
12/224 • Number of events 12 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
13/224 • Number of events 13 • 48 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
7/224 • Number of events 7 • 48 Weeks
|
|
Psychiatric disorders
Depression
|
3.6%
8/224 • Number of events 8 • 48 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place