NCT03372382 (IVY) is a Phase 4 clinical trial of Ibuprofen in Opioid Use, sponsored by The University of Texas Health Science Center, Houston.

Who is sponsoring NCT03372382?

NCT03372382 is sponsored by The University of Texas Health Science Center, Houston.

What drugs are being tested in NCT03372382?

Interventions in NCT03372382: Ibuprofen, Acetaminophen, Norco.

What condition does NCT03372382 study?

NCT03372382 studies Opioid Use, Pain, Postoperative.

Is NCT03372382 still recruiting?

NCT03372382 is currently completed. Last updated 2 July 2019.

Are results published for NCT03372382?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-02 · How we verify

NCT03372382: IVY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section

Completed Phase 4 Results posted Last updated 2 July 2019

What this trial tests

Phase 4 trial testing Ibuprofen in Opioid Use in 170 participants. Completed in 10 April 2018.

Timeline

13 December 2017

Primary endpoint
10 April 2018

10 April 2018

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	170
Start date	13 December 2017
Primary completion	10 April 2018
Estimated completion	10 April 2018
Sites	1 location across United States

Drugs / interventions tested

Ibuprofen (ibuprofen) — full drug profile →
Acetaminophen (Paracetamol) — full drug profile →
Norco — full drug profile →

Conditions studied

Opioid Use — all drugs for Opioid Use →
Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 50, female only, with Opioid Use or Pain, Postoperative. 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.

Pain Level Primary · 2-4 weeks postpartum

pain level measured by objective and subjective scales. 1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean "less pain" and a point towards the right will mean "more pain". After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain.

Group	Value	95% CI
Ibuprofen Plus Acetaminophen	12.3	± 19.5
Ibuprofen Plus Acetaminophen/Hydrocodone	15.9	± 20.4

Patient Satisfaction Secondary · 2-4 weeks postpartum

patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)

Group	Value	95% CI
Ibuprofen Plus Acetaminophen	2
Ibuprofen Plus Acetaminophen/Hydrocodone	4
Ibuprofen Plus Acetaminophen	3
Ibuprofen Plus Acetaminophen/Hydrocodone	3
Ibuprofen Plus Acetaminophen	11
Ibuprofen Plus Acetaminophen/Hydrocodone	12
Ibuprofen Plus Acetaminophen	23
Ibuprofen Plus Acetaminophen/Hydrocodone	16

Adverse events — posted to ClinicalTrials.gov

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

Ibuprofen Plus Acetaminophen

Serious: 0/85 (0%)

Deaths: 0/85

Ibuprofen Plus Acetaminophen/Hydrocodone

Serious: 0/85 (0%)

Deaths: 0/85

Other adverse events (5 terms — click to expand)

Reaction	System	Ibuprofen Plus Acetaminophen	Ibuprofen Plus Acetaminoph…
constipation	Gastrointestinal disorders	—	—
somnolence	General disorders	—	—
nausea / emesis	Gastrointestinal disorders	—	—
GERD	Gastrointestinal disorders	—	—
itching	General disorders	—	—

Data from ClinicalTrials.gov NCT03372382 adverse events section.

Sponsor's own description

Postpartum patients delivered by cesarean section will be randomized to NSAIDS Vs NSAIDS plus opioid

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ibuprofen

Trials testing the same drug.

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Other recruiting trials for Opioid Use

Currently open trials in the same condition.

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NCT06981195 — Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects · Phase 2 · recruiting
NCT06806163 — Machine-Learning Prediction and Reducing Overdoses With EHR Nudges · NA · recruiting
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Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

NCT04200729 — Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-cente · Phase 4 · not yet recruiting
NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services · NA · not yet recruiting
NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03372382 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
Last refreshed: 2 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03372382.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing