Trial Outcomes & Findings for To Evaluate if the Medication Gabapentin Lessens Vulvar Pain (NCT NCT00390013)
NCT ID: NCT00390013
Last Updated: 2017-07-31
Results Overview
change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
19 weeks
Results posted on
2017-07-31
Participant Flow
Study has 2 phases: first was a placebo controlled randomized study (4 participants) second was a cross-over study (5 participants - 2 did not cross over)
Participant milestones
| Measure |
Gabapentin First Then Placebo Crossover
Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Gabapentin: 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
6. days 13-14 you will take 2 capsules 3 times each day
7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
8. at completion of cross-over period 1 you will titrate off study drug over a weeks time.
Placebo:
Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (gabapentin).
|
Placebo Oral Capsule First Then Gabapentin Crossover
Placebo titration and dosing for total of 8 weeks (Cross over)
Placebo oral capsule: Placebo capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
6. days 13-14 you will take 2 capsules 3 times each day
7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2.
8. at completion of study treatment (week 11) you will titrate off study drug over a weeks time.
Gabapentin: 300 mg. capsules Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (placebo).
|
Treatment Only (Gabapentin)
1st phase (placebo controlled study) gabapentin 1800 mg max dose
|
Placebo Control Arm
1 phase Placebo
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
0
|
0
|
2
|
2
|
|
Phase 1
COMPLETED
|
0
|
0
|
2
|
1
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Phase 2 First Treatment
STARTED
|
3
|
2
|
0
|
0
|
|
Phase 2 First Treatment
COMPLETED
|
2
|
1
|
0
|
0
|
|
Phase 2 First Treatment
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Phase 2 Second Treatment
STARTED
|
2
|
1
|
0
|
0
|
|
Phase 2 Second Treatment
COMPLETED
|
2
|
1
|
0
|
0
|
|
Phase 2 Second Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Gabapentin First Then Placebo Crossover
Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Gabapentin: 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
6. days 13-14 you will take 2 capsules 3 times each day
7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
8. at completion of cross-over period 1 you will titrate off study drug over a weeks time.
Placebo:
Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (gabapentin).
|
Placebo Oral Capsule First Then Gabapentin Crossover
Placebo titration and dosing for total of 8 weeks (Cross over)
Placebo oral capsule: Placebo capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
6. days 13-14 you will take 2 capsules 3 times each day
7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2.
8. at completion of study treatment (week 11) you will titrate off study drug over a weeks time.
Gabapentin: 300 mg. capsules Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (placebo).
|
Treatment Only (Gabapentin)
1st phase (placebo controlled study) gabapentin 1800 mg max dose
|
Placebo Control Arm
1 phase Placebo
|
|---|---|---|---|---|
|
Phase 1
tired
|
0
|
0
|
0
|
1
|
|
Phase 2 First Treatment
tired
|
1
|
0
|
0
|
0
|
|
Phase 2 First Treatment
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Baseline characteristics by cohort
| Measure |
All Cross Over Participants
n=5 Participants
Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over)
Gabapentin: 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
1. day 1 you will take 1 capsule for the day
2. day 2 you will take 1 capsule 2 times for that day
3. days 3-6 you will take 1 capsule 3 times for those days
4. days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
5. days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
6. days 13-14 you will take 2 capsules 3 times each day
7. continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
8. at completion of study treatment you will titrate off study drug over a weeks time.
Placebo:
Dosage schedule for cross-over period 2 is the same protocol as cross-over period 1 (Gabapentin).
|
Gabapentin (Phase 1)
n=2 Participants
|
Placebo (Phase 1)
n=2 Participants
|
Total
n=9 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
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 19 weeksPopulation: study terminated early due to poor recruitment
change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain.
Outcome measures
| Measure |
Gabapentin
n=6 Participants
|
Placebo
n=6 Participants
|
|---|---|---|
|
Change From Baseline in Vulvar Pain
|
-1.3 units on a scale
Interval -6.0 to 0.0
|
-1.3 units on a scale
Interval -5.0 to 0.0
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place