Evidence map›Paper›PMID 27229525›Full record

Trial reportClinical drug investigation2016

The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.

Ikuko Yataba, Noboru Otsuka, Isao Matsushita, Hideo Matsumoto, Yuichi Hoshino

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

10 citing papers in PubMed, 21 citations in OpenAlex.

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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.

Ikuko YatabaDevelopment Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
Noboru OtsukaDevelopment Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan. n-otsuka@so.taisho.co.jp.
Isao MatsushitaDevelopment Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
Hideo MatsumotoInstitute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, Japan.
Yuichi HoshinoOrthopedic Surgery, School of Medicine, Jichi Medical University, Tochigi, Japan.
Taisho Pharmaceutical (Japan) · JPJichi Medical University · JPKeio University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThe newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients.

methodsThis was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms.

resultsMost patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment.

conclusionsNo apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.

Indexed as

Administration, TopicalAgedAnti-Inflammatory Agents, Non-SteroidalDermatitis, ContactFemaleFlurbiprofenHumansMaleMiddle AgedOsteoarthritisPainPeptic Ulcer HemorrhageProspective StudiesTransdermal PatchTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalFlurbiprofen

Identifiers

PMID27229525
PMCPMC4951513
OpenAlexW2404808670

What OpenQuestion holds

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LicenceCC BY-NC
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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.