Evidence map›Paper›PMID 27545511›Full record

Trial reportClinical pharmacology in drug development2017

Analgesic Efficacy of a New Immediate-Release/Extended-Release Formulation of Ibuprofen: Results From Single- and Multiple-Dose Postsurgical Dental Pain Studies.

Steven Christensen, Ed Paluch, Shyamalie Jayawardena, Stephen Daniels, Suzanne Meeves

Open access · greenAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Ibuprofen for acute postoperative pain in children.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Three-Dimensional Covalent Organic Framework withACS applied materials & interfaces · 2022
    Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Steven ChristensenJean Brown Research, Salt Lake City, UT, USA.
Ed PaluchPfizer Consumer Healthcare, Madison, NJ, USA.
Shyamalie JayawardenaFormer employee of Pfizer Consumer Healthcare, Madison, NJ, USA.
Stephen DanielsOptimal Research, Rockville, MD, USA.
Suzanne MeevesPfizer Consumer Healthcare, Madison, NJ, USA.
Pfizer (United States) · USJean Brown Research · USOptimal Solutions (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Analgesic effects of ibuprofen immediate-release/extended-release (IR/ER) 600-mg tablets were evaluated in 2 randomized, double-blind, placebo-controlled dental pain studies. Patients 16-40 years old with moderate-severe pain following third-molar extraction received single-dose ibuprofen 600 mg IR/ER (formulation A or B), naproxen sodium 220 mg, or placebo (2:2:2:1; study 1) or 4 doses of ibuprofen 600 mg IR/ER (formulation A) or placebo (1:1; study 2). In study 1 (n = 196), mean (standard deviation [SD]) time-weighted sum of pain intensity difference scores for placebo, ibuprofen IR/ER A, ibuprofen IR/ER B, and naproxen, respectively, were 0.05 (9.2), 16.87 (9.4), 17.34 (10.5), and 12.66 (10.0) over 0-12 hours and -0.03 (4.1), 6.57 (4.4), 7.14 (5.2), and 5.14 (5.0) over 8-12 hours (all P < .001 vs placebo). In study 2 (n = 106), mean (SD) time-weighted sum of pain relief and pain intensity difference scores were 18.2 (20.0) versus 41.5 (21.0) at 0-12 hours and 10.3 (12.0) versus 18.4 (12.1) at 8-12 hours for placebo versus ibuprofen IR/ER, respectively (P < .001 for both); efficacy was sustained over each of the four 12-hour dosing intervals with ibuprofen. Gastrointestinal adverse events predominated with placebo both after study medication administration and after rescue medication use, if applicable. Ibuprofen 600 mg IR/ER provided safe and effective analgesia after single and multiple doses.

Indexed as

AdolescentAdultAnalgesicsDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansIbuprofenMaleNaproxenTabletsToothacheTooth ExtractionTreatment OutcomeAnalgesicsDelayed-Action PreparationsIbuprofenNaproxenTabletsanalgesiadental painextended releaseibuprofenimmediate release

Identifiers

PMID27545511
PMCPMC6093260
OpenAlexW2508645078

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.