Evidence map›Paper›PMID 31010413›Full record

Trial reportBMC musculoskeletal disorders2019

Maintenance of effect of duloxetine in Chinese patients with pain due to osteoarthritis: 13-week open-label extension data.

Guochun Wang, Liqi Bi, Xiangpei Li, Zhijun Li, Dongbao Zhao, Jinwei Chen, Dongyi He, Chia-Ning Wang, Tao Wu, Héctor Dueñas and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC musculoskeletal disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01931475 (Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% 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.

NCT01931475 phase3completednot on this map

Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China

TypeinterventionalSponsorEli Lilly and CompanyRan2013 to 2015Enrolled407ConditionsOsteoarthritisArmsDuloxetine, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. The Mechanism by WhichJournal of inflammation research · 2024
    Article
  7. 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

12 authors at 9 institutions in 2 countries.

Guochun WangRheumatology Department, China-Japan Friendship Hospital, Beijing, China.
Liqi BiRheumatology Department, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China.
Xiangpei LiRheumatology Department, Anhui Provincial Hospital, Hefei, Anhui, China.
Zhijun LiRheumatology Department, Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Dongbao ZhaoRheumatology Department, Shanghai Changhai Hospital, The Second Military Medical University, Shanghai, China.
Jinwei ChenRheumatology Department, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Dongyi HeRheumatology Department, Shanghai Guanghua Hospital, Shanghai, China.
Chia-Ning WangAsian-Pacific Statistical Sciences, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.
Tao WuMedical Department, Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai Branch, Shanghai, China.
Héctor DueñasCorporate Affairs Manager, Latin America Caribbean and Mexico, Eli Lilly de Mexico, Mexico City, Mexico.
Vladimir SkljarevskiLilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
Li YueMedical Department, Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai Branch, 19F, Centre T1, HKRI Taikoo, No. 288, Shimen No.1 Road, Shanghai, 200021, China. yueli97021@126.com.
Lilly (China) · CNAnhui Provincial Hospital · CNBengbu Medical College · CNCentral South University · CNChina-Japan Friendship Hospital · CNEli Lilly (United States) · USJilin University · CNSecond Military Medical University · CNShanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe objectives of this study were to assess the maintenance of effect of duloxetine 60 mg once-daily (QD) in Chinese patients with chronic pain due to osteoarthritis (OA) of the knee or hip and to provide additional long-term safety data.

methodsThis was an open-label, extension phase of a randomized, double-blind, placebo-controlled clinical trial. Eligible patients were outpatients who met the American College of Rheumatology clinical and radiographic criteria for OA with a rating ≥4 on Brief Pain Inventory (BPI) 24-h average pain. After completing the 13-week placebo-controlled phase, patients originally assigned to placebo were titrated to duloxetine 60 mg QD (PLA_DLX), whereas patients originally assigned to duloxetine 60 mg QD remained on the same dose of duloxetine (DLX_DLX) for another 13 weeks. The maintenance effect of duloxetine 60 mg QD during the extension phase was evaluated by a 1-sided 97.5% confidence interval (CI) of the baseline-to-endpoint change in the extension phase for patients who took duloxetine and reported ≥30% reduction in BPI average pain at the end of placebo-controlled phase (placebo-controlled phase duloxetine responders). Other BPI severity and interference items, as well as safety and tolerability, were assessed.

resultsOf 342 patients entering the extension phase, 162 (97.6%) DLX_DLX-treated patients and 157 (89.2%) PLA_DLX-treated patients completed this phase. Most patients (76.0%) were female. Mean age was 60.6 years. Mean BPI average pain was 5.5 at baseline of the placebo-controlled phase. Among 113 placebo-controlled phase duloxetine responders, mean change in BPI average pain during the extension phase was - 0.59 (from 2.47 to 1.88); the upper bound of the 1-sided 97.5% CI was - 0.31 and less than the pre-specified non-inferiority margin of a 1.5-point increase (p < 0.001). Significant within-group improvements in all BPI items were observed for both PLA_DLX and DLX_DLX groups during the extension phase (all p < 0.01). No deaths or suicide-related events occurred. Seven (4.0%) PLA_DLX-treated patients and no DLX_DLX-treated patients discontinued due to an adverse event.

conclusionThe analgesic effect of duloxetine 60 mg QD among treatment responders was maintained for the entire duration of the extension phase. Duloxetine 60 mg QD was well tolerated during the extension phase.

trial registrationClinicalTrials.gov identification number NCT01931475 . Registered 29 August 2013.

Indexed as

AgedAnalgesicsArthralgiaChronic PainDouble-Blind MethodDrug Administration ScheduleDuloxetine HydrochlorideFemaleHumansMaleMiddle AgedOsteoarthritis, HipOsteoarthritis, KneePain MeasurementTreatment OutcomeAnalgesicsDuloxetine HydrochlorideChinaChronic painDuloxetineOsteoarthritis

Identifiers

PMID31010413
PMCPMC6477726
OpenAlexW2941314209

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.