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Analgesic

Ibuprofen + Acetaminophen vs Ibuprofen for Orofacial Pain

Phase < 1
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently not taking antibiotics or analgesics
Healthy with no significant medical findings
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances.
Awards & highlights

Study Summary

This trial will compare the effectiveness of ibuprofen and acetaminophen combined vs ibuprofen alone or placebo in controlling pain after orthodontic appliance placement.

Who is the study for?
This trial is for healthy individuals aged 12 and above who are about to start comprehensive orthodontic treatment, have not taken antibiotics or painkillers recently, and have no allergies to ibuprofen or acetaminophen. It excludes those under 12 or over 80, pregnant women, prisoners, people with decision-making impairments, kidney disease, liver issues, alcoholism, stomach ulcers or bleeding.Check my eligibility
What is being tested?
The study aims to determine if a combination of ibuprofen (200 mg) and acetaminophen (650 mg) is more effective in managing pain after orthodontic appliance placement than just ibuprofen alone or a placebo. Participants will be randomly assigned to one of these three treatments for four days.See study design
What are the potential side effects?
Possible side effects may include gastrointestinal issues like stomach upset or bleeding with ibuprofen use; liver damage from excessive acetaminophen intake; allergic reactions; fatigue; headache; dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently taking any antibiotics or painkillers.
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I am healthy with no major medical issues.
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I am at least 12 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances.
This trial's timeline: 3 weeks for screening, Varies for treatment, and to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in visual analogue score (VAS) over time
Secondary outcome measures
Dosing Compliance

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Ibuprofen and acetaminophenExperimental Treatment1 Intervention
one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
Group II: IbuprofenActive Control1 Intervention
one 200 mg tablet of ibuprofen and 2 placebo tablets
Group III: PlaceboPlacebo Group1 Intervention
3 tablets of tableting compounds with no active ingredients

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,151 Total Patients Enrolled

Media Library

Acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04059172 — Phase < 1
Orofacial Pain Research Study Groups: Placebo, Ibuprofen, Ibuprofen and acetaminophen
Orofacial Pain Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT04059172 — Phase < 1
Acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04059172 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there enrolment vacancies for this trial?

"Affirmative, clinicaltrials.gov lists this study as actively searching for participants. It was published on December 10th 2019 and has been updated most recently on May 13th 2022. This trial is looking to recruit 375 patients from a single site."

Answered by AI

What ailment do Ibuprofen 200 mg and acetaminophen 650 mg typically address?

"Ibuprofen 200 mg and acetaminophen 650 mg are two medicines that can be taken to mitigate the symptoms of catarrh, rhinorrhoea, and musculoskeletal pain."

Answered by AI

What is the cap on individuals taking part in this research effort?

"Affirmative, clinicaltrials.gov indicates that this experiment is presently recruiting patients. It first appeared on December 10th 2019 and was last updated May 13th 2022; 375 individuals across a single site are being sought out for enrollment."

Answered by AI

Have there been any past investigations related to the combination of Ibuprofen 200 mg and acetaminophen 650 mg?

"As of now, the number of live trials involving Ibuprofen 200 mg and acetaminphen 650 mg stands at 109 with a third in Phase 3. Although numerous studies are being conducted out of Pittsburgh, Pennsylvania, there is an expansive network encompassing 1033 sites running these experiments."

Answered by AI

Are there any specific restrictions as to who can participate in this research endeavor?

"The criteria for eligibility includes age parameters between 12 and 80, as well as sufferance of facial pain. This trial is aiming to recruit 375 participants in total."

Answered by AI

Are minors able to partake in this clinical research?

"Those hoping to join this trial must be between the age of 12 and 80. If a person is younger or older than that, there are 39 studies available for minors and 87 options available for seniors."

Answered by AI
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~60 spots leftby Mar 2025