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Opioid Analgesia for MAB

NCT03139240 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2019-08-28

Study results available
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Summary

Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study will help future providers understand whether prescribing opioids are an important adjunct for pain control in women undergoing MAB.

Conditions

Interventions

DRUG

Oxycodone 10mg oral

Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion

OTHER

Placebo

Placebo given in addition to standard of care medications in women undergoing medical abortion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-05-31
Completion
2018-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139240 on ClinicalTrials.gov