Trial Outcomes & Findings for Prophylactic Pregabalin to Decrease Pain During Medical Abortion (NCT NCT02782169)
NCT ID: NCT02782169
Last Updated: 2018-04-19
Results Overview
reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Results posted on
2018-04-19
Participant Flow
Participant milestones
| Measure |
Pregabalin
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
|
Overall Study
COMPLETED
|
55
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Pregabalin
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Prophylactic Pregabalin to Decrease Pain During Medical Abortion
Baseline characteristics by cohort
| Measure |
Pregabalin
n=55 Participants
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
n=52 Participants
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.25 years
STANDARD_DEVIATION 5.45 • n=5 Participants
|
27.19 years
STANDARD_DEVIATION 6.02 • n=7 Participants
|
27.22 years
STANDARD_DEVIATION 5.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain
Outcome measures
| Measure |
Pregabalin
n=55 Participants
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
n=52 Participants
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
|---|---|---|
|
Maximum Pain Score Over Study Period
|
5.0 units on a scale
Standard Deviation 2.6
|
5.5 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)summed number of tablets used by each participant over the 72 hour study period
Outcome measures
| Measure |
Pregabalin
n=55 Participants
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
n=52 Participants
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
|---|---|---|
|
Number of Ibuprofen 800mg Tablets Used
|
1 tablets
Interval 0.0 to 4.0
|
2 tablets
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)summed number of tablets used by each participant over the 72 hour study period
Outcome measures
| Measure |
Pregabalin
n=55 Participants
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
n=52 Participants
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
|---|---|---|
|
Number of Oxycodone/Acetominophen Tablets (5/325mg) Used
|
0 tablets
Interval 0.0 to 1.0
|
0.5 tablets
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.
Outcome measures
| Measure |
Pregabalin
n=55 Participants
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
n=52 Participants
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
|---|---|---|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Nausea
|
43 participants
|
42 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Vomiting
|
28 participants
|
30 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Sleepiness
|
47 participants
|
39 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Dizziness
|
45 participants
|
26 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Headache
|
28 participants
|
17 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Blurred Vision
|
15 participants
|
7 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Diarrhea
|
28 participants
|
29 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Constipation
|
6 participants
|
15 participants
|
|
Number of Participants Ever Experiencing Different Symptoms During Abortion
Dry Mouth
|
22 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Asked at time point of 24 hours5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)
Outcome measures
| Measure |
Pregabalin
n=55 Participants
Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
|
Placebo
n=52 Participants
Placebo: Matching placebo capsule with excipient to match Pregabalin
|
|---|---|---|
|
Satisfaction With Analgesia
Very dissatisfied
|
2 Participants
|
3 Participants
|
|
Satisfaction With Analgesia
Dissatisfied
|
3 Participants
|
0 Participants
|
|
Satisfaction With Analgesia
Neutral
|
12 Participants
|
13 Participants
|
|
Satisfaction With Analgesia
Satisfied
|
11 Participants
|
24 Participants
|
|
Satisfaction With Analgesia
Very satisfied
|
25 Participants
|
11 Participants
|
|
Satisfaction With Analgesia
No response
|
2 Participants
|
1 Participants
|
Adverse Events
Pregabalin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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