NCT03139240

Opioid Analgesia for MAB

Completed Phase 4 Results posted Last updated 28 August 2019

What this trial tests

Phase 4 trial testing Oxycodone 10mg oral in MAB in 172 participants. Completed in 31 May 2018.

Timeline

1 May 2017

Primary endpoint
31 May 2018

31 May 2018

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	172
Start date	1 May 2017
Primary completion	31 May 2018
Estimated completion	31 May 2018
Sites	1 location across United States

Drugs / interventions tested

• Oxycodone 10mg oral
• Placebo

Conditions studied

• MAB — all drugs for MAB →
• Pain — all drugs for Pain →

Sponsor

Oregon Health and Science University

Who can join

Adults 18 to 50, female only, with MAB or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Maximum Self-reported Pain Score Primary · 24 hours after misoprostol administration

Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).

Group	Value	95% CI
Oxycodone Arm	8	2 – 10
Placebo Arm	8	1 – 10

<7 Weeks of Gestation - Maximum Self-reported Pain Score Primary · 24 hours after misoprostol administration

Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).

Group	Value	95% CI
Oxycodone	8	2 – 10
Placebo	8	1 – 10

7-10 Weeks Gestation - Maximum Self-reported Pain Score Primary · 24 hours after misoprostol administration

Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).

Group	Value	95% CI
Oxycodone	9	2 – 10
Placebo	8	4 – 10

Adverse events — posted to ClinicalTrials.gov

Time frame: 21 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oxycodone

Serious: 0/86 (0%)

Deaths: 0/86

Placebo

Serious: 0/86 (0%)

Deaths: 0/86

Other adverse events (1 terms — click to expand)

Reaction	System	Oxycodone	Placebo
Ongoing pregnancy	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT03139240 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.
   Colwill AC, Bayer LL, Bednarek P, Garg B, et al · · 2019 · cited 24× · PMID 31764725 · DOI 10.1097/aog.0000000000003576
2. Pain management for medical abortion before 14 weeks' gestation.
   Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. · · 2022 · cited 7× · PMID 35553047 · DOI 10.1002/14651858.cd013525.pub2