A Phase 4 interventional study of Pregabalin and Placebo in Acute Pain, sponsored by University of Hawaii. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-19.
Sponsored by University of Hawaii · Phase 4, Interventional, and Treatment
Medical abortion has been associated with significant pain. The objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. Investigators will perform a randomized, double-blinded, placebo-controlled trial. Participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 110 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Hawaii is the lead sponsor of 95 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Pregabalin
Drug: Placebo
Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
Matching placebo capsule with excipient to match Pregabalin
Maximum Pain Score Over Study Period
reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Number of Ibuprofen 800mg Tablets Used
summed number of tablets used by each participant over the 72 hour study period
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Number of Oxycodone/Acetominophen Tablets (5/325mg) Used
summed number of tablets used by each participant over the 72 hour study period
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Number of Participants Ever Experiencing Different Symptoms During Abortion
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.
Time frame: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
Satisfaction With Analgesia
5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)
Time frame: Asked at time point of 24 hours
| Milestone | Pregabalin | Placebo |
|---|---|---|
| Started | 56 | 54 |
| Completed | 55 | 52 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Maximum Pain Score Over Study Period | 5.0 ± 2.6 | 5.5 ± 2.2 |
summed number of tablets used by each participant over the 72 hour study period
| tablets | Pregabalin | Placebo |
|---|---|---|
| Number of Ibuprofen 800mg Tablets Used | 1 (0 to 4) | 2 (1 to 3) |
summed number of tablets used by each participant over the 72 hour study period
| tablets | Pregabalin | Placebo |
|---|---|---|
| Number of Oxycodone/Acetominophen Tablets (5/325mg) Used | 0 (0 to 1) | 0.5 (0 to 1) |
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.
| participants | Pregabalin | Placebo |
|---|---|---|
| Nausea | 43 | 42 |
| Vomiting | 28 | 30 |
| Sleepiness | 47 | 39 |
| Dizziness | 45 | 26 |
| Headache | 28 | 17 |
| Blurred Vision | 15 | 7 |
| Diarrhea | 28 | 29 |
| Constipation | 6 | 15 |
| Dry Mouth | 22 | 25 |
5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)
| Participants | Pregabalin | Placebo |
|---|---|---|
| Very dissatisfied | 2 | 3 |
| Dissatisfied | 3 | 0 |
| Neutral | 12 | 13 |
| Satisfied | 11 | 24 |
| Very satisfied | 25 | 11 |
| No response | 2 | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Placebo | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Mean | 27.25 ± 5.45 | 27.19 ± 6.02 | 27.22 ± 5.71 |
| Sex: Female, Male(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Female | 55 | 52 | 107 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 18 | 12 | 30 |
| Native Hawaiian or Other Pacific Islander | 5 | 6 | 11 |
| Black or African American | 1 | 2 | 3 |
| White | 6 | 8 | 14 |
| More than one race | 23 | 21 | 44 |
| Unknown or Not Reported | 2 | 3 | 5 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Hawaii