Ibuprofen and acetaminophen for Opioid Use Disorder

Pennsylvania State University Hershey Medical Center, Hershey, PA
Opioid Use Disorder+1 More ConditionsAcetaminophen - Drug
What conditions do you have?

Study Summary

This trial is testing if a combination of acetaminophen and ibuprofen is more effective than ibuprofen alone in relieving post-operative pain for patients who have had a Cesarean delivery.

Eligible Conditions
  • Opioid Use Disorder
  • Postoperative Pain

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Day 2 morning (4 am - 10 am)

Day 1
Pain score post operative day 1 PM
Day 1
Pain score post-operative day 1 mid-day
Day 14
WHOQOL-BREF score, domain 1
WHOQOL-BREF score, domain 2
WHOQOL-BREF score, domain 3
WHOQOL-BREF score, domain 4
Day 2
Pain score post operative day 2 PM
Day 2
Pain score post operative day 2 AM
Day 3
Pain score post operative day 3 AM
Day 1
Opiate consumption in hospital
post-discharge days 1-7
Opiate consumption week 1
post-discharge days 8-14
Opiate consumption week 2
second post-operative day (mid-day, 12 PM - 4 PM)

Trial Safety

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Ibuprofen and acetaminophen
1 of 2
Ibuprofen and placebo
1 of 2

Active Control

Non-Treatment Group

144 Total Participants · 2 Treatment Groups

Primary Treatment: Ibuprofen and acetaminophen · Has Placebo Group · Phase 3

Ibuprofen and acetaminophenActiveComparator Group · 2 Interventions: Acetaminophen, Ibuprofen · Intervention Types: Drug, Drug
Ibuprofen and placeboPlaceboComparator Group · 2 Interventions: Placebo, Ibuprofen · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 2 morning (4 am - 10 am)

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
469 Previous Clinical Trials
2,785,615 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You had a cesarean section with a transverse incision in the lower part of your uterus.

Frequently Asked Questions

What is the most up-to-date information on Ibuprofen and acetaminophen's FDA approval status?

"Both Ibuprofen and acetaminophen have extensive Phase 3 trial data supporting their efficacy and safety, so they each received a score of 3." - Anonymous Online Contributor

Unverified Answer

How many test subjects are a part of this experiment?

"The clinicaltrials.gov website contains information indicating that this study is currently looking for patients to enroll. This trial was originally posted on 8/5/2019, and the most recent update was on 9/26/2022. A total of 144 patients are needed from 1 location." - Anonymous Online Contributor

Unverified Answer

For what primary reasons are people taking Ibuprofen and acetaminophen?

"Inflammation of the mucous membranes, excessive discharge of mucus from the nose, and pain in the muscles and bones can all be treated using Ibuprofen and acetaminophen." - Anonymous Online Contributor

Unverified Answer

Are new participants currently being sought for this experiment?

"From what is available on clinicaltrials.gov, this study is still recruiting patients and seeking new participants. The trial was originally posted on 8/5/2019, with the most recent update being 9/26/2022." - Anonymous Online Contributor

Unverified Answer

Could you please list other research projects that have studied Ibuprofen and acetaminophen?

"Currently, there are 118 ongoing trials studying the effects of ibuprofen and acetaminophen. Of these active studies, 36 are in Phase 3. Most of the research regarding Ibuprofen and acetaminophen is centred in Pittsburgh, Pennsylvania; however, there are 1037 locations running these types of trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.