Trial Outcomes & Findings for Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve (NCT NCT01886313)
NCT ID: NCT01886313
Last Updated: 2017-03-01
Results Overview
The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-03-01
Participant Flow
Participants were recruited based on physician referral at 5 centers in the United States.
Subjects who met a minimum average daily pain score of ≥4 were equally randomized into either active or placebo groups.
Participant milestones
| Measure |
Double Blind Treatment Period Civamide Nasal Spray
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray
|
Double Blind Treatment Period Placebo Nasal Spray
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Double Blind Treatment Period Civamide Nasal Spray
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray
|
Double Blind Treatment Period Placebo Nasal Spray
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Civamide Nasal Solution for Postherpetic Neuralgia of the Trigeminal Nerve
Baseline characteristics by cohort
| Measure |
Double Blind Treatment Period Civamide Nasal Spray
n=6 Participants
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray
|
Double Blind Treatment Period Placebo Nasal Spray
n=5 Participants
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Gender
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Gender
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 1 patient withdrew early from study
The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.
Outcome measures
| Measure |
Double Blind Treatment Period Civamide Nasal Spray
n=6 Participants
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray
|
Double Blind Treatment Period Placebo Nasal Spray
n=5 Participants
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo
|
|---|---|---|
|
Average Daily Pain Score
Baseline
|
6.4 units on a scale
Standard Deviation 0.84
|
5.2 units on a scale
Standard Deviation 1.02
|
|
Average Daily Pain Score
Week 6
|
5.3 units on a scale
Standard Deviation 1.24
|
3.1 units on a scale
Standard Deviation 2.13
|
Adverse Events
Double Blind Treatment Period Civamide Nasal Spray
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Double Blind Treatment Period Placebo Nasal Spray
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double Blind Treatment Period Civamide Nasal Spray
n=6 participants at risk
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray
|
Double Blind Treatment Period Placebo Nasal Spray
n=5 participants at risk
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
20.0%
1/5 • Number of events 1 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
Other adverse events
| Measure |
Double Blind Treatment Period Civamide Nasal Spray
n=6 participants at risk
Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks
Civamide Nasal Spray
|
Double Blind Treatment Period Placebo Nasal Spray
n=5 participants at risk
Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks
Placebo
|
|---|---|---|
|
General disorders
Application Site Burning
|
50.0%
3/6 • Number of events 11 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
20.0%
1/5 • Number of events 1 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
General disorders
Application Site Irritation
|
50.0%
3/6 • Number of events 17 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
40.0%
2/5 • Number of events 3 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
16.7%
1/6 • Number of events 4 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
16.7%
1/6 • Number of events 3 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
20.0%
1/5 • Number of events 1 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Nervous system disorders
Neuralgia
|
16.7%
1/6 • Number of events 2 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/6 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
20.0%
1/5 • Number of events 1 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
16.7%
1/6 • Number of events 1 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
16.7%
1/6 • Number of events 1 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
16.7%
1/6 • Number of events 1 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 6 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
|
Eye disorders
Eye Irriation
|
16.7%
1/6 • Number of events 2 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
0.00%
0/5 • 6 week Treatment Period, 2 week Post Treatment Observation Period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place