MABPhase 4NCT03139240

Opioid Analgesia for MAB

A Phase 4 study testing Oxycodone 10mg oral in people with MAB and Pain, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: MAB, Pain
What is being tested?: Oxycodone 10mg oral
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 172 participants
Where: 1 siteUnited States
Study dates: 1 May 2017to 31 May 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18 years or older
Seeking elective medical abortion
In good health
Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
Able and willing to receive text messages via phone
Literate in English
Able and willing to give informed consent and agree to the study terms
Have assistance at home; no motor vehicle use while taking study medications

Who cannot join

Lack of access to cell phone and texting capabilities
Early pregnancy failure
Contraindications to the study medications: Oxycodone, Ibuprofen
Contraindications to medical abortion with Mifepristone or Misoprostol
History of methadone or heroin use
Used alcohol in the past 24 hours

Show all 9Show fewer

Used marijuana >4 times per week
Any opioid in the past 30 days
Using additional pain medications

Trial locations and contacts

1 site in 1 country.

United States1 site

Site 1
Beaverton, Oregon, 97005

Other trials in United States

About this study

Official title: Opioid Analgesia for MAB: A Randomized Controlled Trial

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.

Read the detailed description

This study will include 152 women undergoing MAB. Women will be randomized to oxycodone 10mg oral versus placebo and stratified by gestational age (<7wks, 7-10wks). The primary outcome will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol administration.

Conditions: MAB, Pain
Being tested: Oxycodone 10mg oral, Placebo
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03139240
Study group	Role	What they receive
Gestational age <7 weeks	Experimental	Women with a gestational age <7 weeks will be randomized to oxycodone 10mg oral vs placebo Receives: Drug: Oxycodone 10mg oral; Other: Placebo
Gestational age 7-10w0d	Experimental	Women with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo Receives: Drug: Oxycodone 10mg oral; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Maximum Self-reported Pain Score
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).
Measured: 24 hours after misoprostol administration
<7 Weeks of Gestation - Maximum Self-reported Pain Score
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).
Measured: 24 hours after misoprostol administration
7-10 Weeks Gestation - Maximum Self-reported Pain Score
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).
Measured: 24 hours after misoprostol administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201731 May 2018

First posted3 May 2017
Study start1 May 2017
Primary completion31 May 2018
Study completion31 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MABStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03139240
Sponsor's protocol ID: 16845
Status last verified: Aug 2019
First submitted: 28 Apr 2017
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Colwill AC, Bayer LL, Bednarek P, Garg B, Jensen JT, Edelman AB. Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1163-1170. doi: 10.1097/AOG.0000000000003576.
PubMed 31764725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Opioid Analgesia for MAB: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03139240
Acronym / sponsor ID: 16845
Conditions: MAB, Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: Society of Family Planning
Study start: 1 May 2017 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 3 May 2017 (actual)
Results: Posted 13 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Gestational age <7 weeks	Experimental	Drug: Oxycodone 10mg oral, Other: PlaceboWomen with a gestational age <7 weeks will be randomized to oxycodone 10mg oral vs placebo
Gestational age 7-10w0d	Experimental	Drug: Oxycodone 10mg oral, Other: PlaceboWomen with a gestational age 7-10w0d will be randomized to oxycodone 10mg oral vs placebo

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Aged 18 years or older
Seeking elective medical abortion
In good health
Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
Able and willing to receive text messages via phone

Key exclusion criteria (9 listed)

Lack of access to cell phone and texting capabilities
Early pregnancy failure
Contraindications to the study medications: Oxycodone, Ibuprofen
Contraindications to medical abortion with Mifepristone or Misoprostol
History of methadone or heroin use

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxycodone 10mg oralOxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion	Drug	Gestational age 7-10w0d, Gestational age <7 weeks
PlaceboPlacebo given in addition to standard of care medications in women undergoing medical abortion	Other	Gestational age 7-10w0d, Gestational age <7 weeks

Primary outcome

Overall Maximum Self-reported Pain Score
Time frame: 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).
<7 Weeks of Gestation - Maximum Self-reported Pain Score
Time frame: 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).
7-10 Weeks Gestation - Maximum Self-reported Pain Score
Time frame: 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).

Results and safety

Results posted to the registry on 13 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxycodone: <7 Weeks of Gestation	48	48
Placebo: <7 Weeks Gestational Age	48	47
Oxycodone: 7-10w0d Gestational Age	38	37
Placebo: 7-10w0d Gestational Age	38	38

Primary outcome: Overall Maximum Self-reported Pain Score

Time frame: 24 hours after misoprostol administration. Median (Full Range). Unit: units on a scale

Measure	Oxycodone Arm n = 86	Placebo Arm n = 86
Value	8 (2 to 10)	8 (1 to 10)

Primary outcome: <7 Weeks of Gestation - Maximum Self-reported Pain Score

Time frame: 24 hours after misoprostol administration. Median (Full Range). Unit: units on a scale

Measure	Oxycodone n = 48	Placebo n = 47
Value	8 (2 to 10)	8 (1 to 10)

Population analysed: Participants at \<7 weeks of Gestation were assessed. Participants who were "lost to follow-up" were excluded from this analysis.

Primary outcome: 7-10 Weeks Gestation - Maximum Self-reported Pain Score

Time frame: 24 hours after misoprostol administration. Median (Full Range). Unit: units on a scale

Measure	Oxycodone n = 37	Placebo n = 38
Value	9 (2 to 10)	8 (4 to 10)

Population analysed: Participants at 7-10w0d of Gestation were assessed. Participants who were "lost to follow-up" were excluded from this analysis.

Adverse events

Time frame: 21 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxycodone	0 of 86 (0%)	4 of 86 (4.7%)	0 of 86
Placebo	0 of 86 (0%)	2 of 86 (2.3%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31764725Colwill AC, Bayer LL, Bednarek P, Garg B, Jensen JT, Edelman AB. Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1163-1170. doi: 10.1097/AOG.0000000000003576.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxycodone 10mg oral in people with MAB and Pain, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Maximum Self-reported Pain Score (time frame: 24 hours after misoprostol administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03139240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.