Trial Outcomes & Findings for Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia (NCT NCT01426230)
NCT ID: NCT01426230
Last Updated: 2013-03-21
Results Overview
Change from baseline in pain score on visual analog scale (VAS) (intensity scored from "No Pain" (0mm) to "Worst Possible Pain" (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis
Recruitment status
COMPLETED
Target enrollment
201 participants
Primary outcome timeframe
8 weeks (Baseline and Week 8)
Results posted on
2013-03-21
Participant Flow
201 patients were enrolled, but only 197 patients received study treatment.
Participant milestones
| Measure |
Open Label - Cohort >70 Yrs Old
Cohort by age-
\- Patients \>70 Yrs old
|
Open Label - Cohort <=70 Yrs Old
Cohort by age-
\- Patients \<=70 Yrs old
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
111
|
|
Overall Study
COMPLETED
|
55
|
84
|
|
Overall Study
NOT COMPLETED
|
31
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
Baseline characteristics by cohort
| Measure |
Open Label - Cohort <=70 Yrs Old
n=111 Participants
Cohort by age-
\- Patients \<=70 Yrs old
|
Total
n=197 Participants
Total of all reporting groups
|
Open Label - Cohort >70 Yrs Old
n=86 Participants
Cohort by age-
\- Patients \>70 Yrs old
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
86 Participants
n=5 Participants
|
|
Age Continuous
|
59.0 years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 12.79 • n=5 Participants
|
78.2 years
STANDARD_DEVIATION 5.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=7 Participants
|
197 participants
n=5 Participants
|
86 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks (Baseline and Week 8)Population: The Number of Participants Analyzed was based on the available VAS.
Change from baseline in pain score on visual analog scale (VAS) (intensity scored from "No Pain" (0mm) to "Worst Possible Pain" (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis
Outcome measures
| Measure |
Open Label - Cohort >70 Yrs Old
n=80 Participants
Cohort by age-
\- Patients \>70 Yrs old
|
Open Label - Cohort <=70 Yrs Old
n=110 Participants
Cohort by age-
\- Patients \<=70 Yrs old
|
|---|---|---|
|
Change From Baseline to End of Study in LOCF VAS
|
-20.4 scores on a scale
Interval -26.5 to -14.4
|
-21.3 scores on a scale
Interval -26.8 to -15.8
|
Adverse Events
Open Label - Both Cohorts
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label - Both Cohorts
n=197 participants at risk
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.51%
1/197 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.51%
1/197 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.51%
1/197 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.51%
1/197 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.51%
1/197 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.51%
1/197 • Number of events 1
|
Other adverse events
| Measure |
Open Label - Both Cohorts
n=197 participants at risk
|
|---|---|
|
Nervous system disorders
Dizziness
|
13.7%
27/197 • Number of events 28
|
|
Nervous system disorders
Somnolence
|
5.6%
11/197 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and/or proprietary other than study data.
- Publication restrictions are in place
Restriction type: OTHER