At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 110 enrolled

Drug / intervention

Pregabalin +1 moredrug

Likely dose

Pregabalin 300 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02782169

NCT02782169Phase 4Completed

Compare CT.gov

Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial

University of Hawaii·interventional·Posted May 25, 2016·Updated Apr 19, 2018

In Brief

A Phase 4 clinical trial evaluating Pregabalin and Placebo for Acute Pain. Completed, enrolled 110 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAcute Pain

CountriesUnited States

CollaboratorsSociety of Family Planning

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartJun 2015

First PostedMay 2016

Primary CompletionOct 2016

Study CompletionDec 2016

TodayJul 2026

First PostedMay 25, 2016

Enrollment StartJun 1, 2015

Primary CompletionOct 1, 2016

Study CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 10.1 years ago

Interventions

Pregabalindrug

Pregabalin 300 mg capsule (over encapsulated to maintain blinding)

Placebodrug

Matching placebo capsule with excipient to match Pregabalin