Trial Outcomes & Findings for A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response (NCT NCT01301001)
NCT ID: NCT01301001
Last Updated: 2017-11-08
Results Overview
Tampon pain on a 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). One tampon was inserted each week. Tampon pain was assessed during last week of maintenance phase (7 days).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome timeframe
Week 6 for each treatment arm
Results posted on
2017-11-08
Participant Flow
Participants were recruited between August 8, 2012 and January 19, 2016 from three academic centers.
230 women were screened, 89 met entry criteria and 66 completed the trial. Of the 141 patients who were excluded prior to randomization, 16 decided not to participate in the trial,101 did not meet inclusion criteria, and 24 did not return for randomization.
Participant milestones
| Measure |
Placebo First, Then Gabepentin
Placebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period)
Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm
Gabapentin: Gabapentin 1200 mg am and 1800 mg pm
|
Gabapentin First, Then Placebo
Gabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)
Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm
Gabapentin: Gabapentin 1200 mg am and 1800 mg pm
|
|---|---|---|
|
First Intervention
STARTED
|
44
|
45
|
|
First Intervention
COMPLETED
|
34
|
36
|
|
First Intervention
NOT COMPLETED
|
10
|
9
|
|
Washout (2 Weeks)
STARTED
|
34
|
36
|
|
Washout (2 Weeks)
COMPLETED
|
34
|
36
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
34
|
36
|
|
Second Intervention
COMPLETED
|
30
|
36
|
|
Second Intervention
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Placebo First, Then Gabepentin
Placebo capsule daily in first intervention period and Gabapentin capsule 3000 mg daily in in second intervention (after washout period)
Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm
Gabapentin: Gabapentin 1200 mg am and 1800 mg pm
|
Gabapentin First, Then Placebo
Gabapentin capsule 3000 mg daily in first intervention period and Placebo capsule in second intervention (after washout period)
Placebo oral capsule: Placebo 2 capsules am and 3 capsules pm
Gabapentin: Gabapentin 1200 mg am and 1800 mg pm
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
4
|
4
|
|
First Intervention
Withdrawal by Subject
|
1
|
4
|
|
First Intervention
Adverse Event
|
5
|
0
|
|
First Intervention
Protocol Violation
|
0
|
1
|
|
Second Intervention
Adverse Event
|
2
|
0
|
|
Second Intervention
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Trial of Gabapentin in Vulvodynia: Biological Correlates of Response
Baseline characteristics by cohort
| Measure |
All Study Participants
n=89 Participants
44 subjects were randomized to Placebo First and 45 subjects were randomized to Gabapentin First
|
|---|---|
|
Age, Continuous
|
36.54 years
STANDARD_DEVIATION 2.30 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
89 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6 for each treatment armPopulation: Intention to Treat
Tampon pain on a 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). One tampon was inserted each week. Tampon pain was assessed during last week of maintenance phase (7 days).
Outcome measures
| Measure |
Placebo
n=89 Participants
2 capsules am and 3 capsules pm
|
Gabapentin
n=89 Participants
2 capsules (1200 mg) am and 3 capsules (1800 mg) pm
|
|---|---|---|
|
Tampon Test Pain Intensity
|
4.29 units on a scale
Interval 3.37 to 5.22
|
3.96 units on a scale
Interval 3.03 to 4.89
|
SECONDARY outcome
Timeframe: Week 6 of each treatment armPopulation: Intent to treat
Coital pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever), assessed after each sexual intercourse event. The number of sexual intercourse events was averaged during final week of each treatment arm.
Outcome measures
| Measure |
Placebo
n=89 Participants
2 capsules am and 3 capsules pm
|
Gabapentin
n=89 Participants
2 capsules (1200 mg) am and 3 capsules (1800 mg) pm
|
|---|---|---|
|
Coital Pain
|
3.97 units on a scale
Interval 2.5 to 5.44
|
3.85 units on a scale
Interval 2.36 to 5.34
|
SECONDARY outcome
Timeframe: Week 6 for each treatment armOverall vulvodynia pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). Pain was assessed daily during the last week of treatment. Daily scores were averaged.
Outcome measures
| Measure |
Placebo
n=89 Participants
2 capsules am and 3 capsules pm
|
Gabapentin
n=89 Participants
2 capsules (1200 mg) am and 3 capsules (1800 mg) pm
|
|---|---|---|
|
Vulvodynia Pain
|
2.88 units on a scale
Interval 1.99 to 3.76
|
2.71 units on a scale
Interval 1.82 to 3.59
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=89 participants at risk
2 capsules am and 3 capsules pm
|
Gabapentin
n=89 participants at risk
2 capsules (1200 mg) am and 3 capsules (1800) mg pm
|
|---|---|---|
|
Cardiac disorders
unstable angina and malignant hypertension
|
1.1%
1/89 • Number of events 1 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
0.00%
0/89 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
asthma with acute exacerbation
|
1.1%
1/89 • Number of events 1 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
0.00%
0/89 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Nervous system disorders
cluster headache
|
1.1%
1/89 • Number of events 1 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
0.00%
0/89 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
Other adverse events
| Measure |
Placebo
n=89 participants at risk
2 capsules am and 3 capsules pm
|
Gabapentin
n=89 participants at risk
2 capsules (1200 mg) am and 3 capsules (1800) mg pm
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
3.4%
3/89 • Number of events 3 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
10.1%
9/89 • Number of events 17 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Nervous system disorders
Fatigue
|
1.1%
1/89 • Number of events 1 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
5.6%
5/89 • Number of events 7 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
5.6%
5/89 • Number of events 7 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
7.9%
7/89 • Number of events 15 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Nervous system disorders
Somnolence
|
4.5%
4/89 • Number of events 4 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
7.9%
7/89 • Number of events 7 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Infections and infestations
Rhinitis
|
4.5%
4/89 • Number of events 4 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
11.2%
10/89 • Number of events 14 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
3.4%
3/89 • Number of events 4 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
9.0%
8/89 • Number of events 13 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
|
Infections and infestations
Bacterial Vaginosis
|
4.5%
4/89 • Number of events 4 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
7.9%
7/89 • Number of events 7 • 16 weeks
Definition of adverse events is the same as clinicaltrials.gov
|
Additional Information
Dr. Candace Brown
University of Tennessee Health Science Center
Phone: 9014124341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place