Trial Outcomes & Findings for A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN) (NCT NCT00475904)
NCT ID: NCT00475904
Last Updated: 2011-07-27
Results Overview
Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
COMPLETED
PHASE2
360 participants
baseline and 28 days
2011-07-27
Participant Flow
Participant milestones
| Measure |
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules
amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
|
Gabapentin Capsules, Placebo Cream
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
|
Placebo Cream and Capsules
placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
140
|
144
|
76
|
|
Overall Study
COMPLETED
|
125
|
131
|
72
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Baseline characteristics by cohort
| Measure |
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules
n=140 Participants
amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
|
Gabapentin Capsules, Placebo Cream
n=144 Participants
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
|
Placebo Cream and Capsules
n=76 Participants
placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
|
Total
n=360 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
270 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Age Continuous
|
51.3 years
STANDARD_DEVIATION 16.04 • n=99 Participants
|
53.2 years
STANDARD_DEVIATION 15.53 • n=107 Participants
|
53.2 years
STANDARD_DEVIATION 16.47 • n=206 Participants
|
52.5 years
STANDARD_DEVIATION 15.91 • n=7 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
135 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
225 Participants
n=7 Participants
|
|
Region of Enrollment
India
|
140 participants
n=99 Participants
|
144 participants
n=107 Participants
|
76 participants
n=206 Participants
|
360 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline and 28 daysPopulation: This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.
Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
Outcome measures
| Measure |
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules
n=135 Participants
amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
|
Gabapentin Capsules, Placebo Cream
n=138 Participants
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
|
Placebo Cream and Capsules
n=76 Participants
placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
|
|---|---|---|---|
|
Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.
|
2.424 units on a scale
Interval 2.07 to 2.78
|
2.471 units on a scale
Interval 2.17 to 2.77
|
1.877 units on a scale
Interval 1.43 to 2.32
|
PRIMARY outcome
Timeframe: baseline to 28 DaysPopulation: Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique
Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
Outcome measures
| Measure |
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules
n=135 Participants
amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
|
Gabapentin Capsules, Placebo Cream
n=138 Participants
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
|
Placebo Cream and Capsules
n=76 Participants
placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
|
|---|---|---|---|
|
Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin
|
2.424 units on a scale
Interval 2.07 to 2.7
|
2.471 units on a scale
Interval 2.17 to 2.77
|
1.877 units on a scale
Interval 1.43 to 2.3
|
Adverse Events
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules
Gabapentin Capsules, Placebo Cream
Placebo Cream and Capsules
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules
n=140 participants at risk
amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
|
Gabapentin Capsules, Placebo Cream
n=144 participants at risk
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
|
Placebo Cream and Capsules
n=76 participants at risk
placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
7/140 • Number of events 7
|
1.4%
2/144 • Number of events 2
|
1.3%
1/76 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place