Evidence map›Paper›PMID 35573994›Full record

Trial reportFrontiers in endocrinology2022

A Randomized Controlled Phase 3 Study on the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Idiopathic Short Stature.

Jinna Yuan, Junfen Fu, Haiyan Wei, Gaixiu Zhang, Yanfeng Xiao, Hongwei Du, Wei Gu, Yanhong Li, Linqi Chen, Feihong Luo and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in endocrinology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03635580 (Phase 2 Study of Efficacy and Safety of rhGH), which is not on this 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
–field-weighted citation impact
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.

NCT03635580 phase3unknown statusnot on this map

Phase 2 Study of Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS (Idiopathic Short Stature): a 52-week Multicenter, Open-label, Randomized, Negative Controlled Study Followed by a 52-week Open-label Period

TypeinterventionalSponsorChangchun GeneScience Pharmaceutical Co., Ltd.Ran2018 to 2021Enrolled480ConditionsDwarfismArmsNegative control
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Pooled it
  3. Article
  4. Observational
  5. Observational
  6. Article
  7. Article
  8. Long-Term Efficacy and Safety of Recombinant Human Growth Hormone in Children Born Small for Gestational Age.Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2023
    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.

Jinna YuanEndocrinology Department, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Junfen FuEndocrinology Department, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
Haiyan WeiDepartment of Endocrinology, Genetics and Metabolism, Zhengzhou Children's Hospital, Zhengzhou, China.
Gaixiu ZhangDepartment of Pediatrics and Endocrinology, Children's Hospital of Shanxi, Taiyuan, China.
Yanfeng XiaoDepartment of Pediatrics, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Hongwei DuDepartment of Pediatrics and Endocrinology, The First Hospital of Jilin University, Jilin, China.
Wei GuDepartment of Endocrinology, Nanjing Children's Hospital, Nanjing, China.
Yanhong LiDepartment of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Linqi ChenDepartment of Endocrinology, Genetics and Metabolism, Children's Hospital of Soochow University, Suzhou, China.
Feihong LuoDepartment of Endocrinology, Children's Hospital of Fudan University, Shanghai, China.
Yan ZhongChildren Health Division, Hunan Children's Hospital, Changsha, China.
Haihong GongDepartment of Pediatrics, Jiangsu Provincial People's Hospital, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: To evaluate the safety and efficacy of daily somatropin (Jintropin Methods: This study was a multicenter, randomized, controlled, open-label, phase 3 study. All subjects were randomized 3:1 to daily somatropin 0.05 mg/kg/day or no treatment for 52 weeks. A total of 481 subjects with a mean baseline age of 5.8 years were enrolled in the study. The primary endpoint was change in (△) height standard deviation score (HT-SDS) for chronological age (CA). Secondary endpoints included △height from baseline; △bone age (BA)/CA; △height velocity (HV) and △insulin-like growth factor 1 (IGF-1 SDS). Results: △HT-SDS at week 52 was 1.04 ± 0.31 in the treatment group and 0.20 ± 0.33 in the control group ( Conclusions: Daily subcutaneous administration of somatropin at 0.05 mg/kg/day for 52 weeks demonstrated improvement in growth outcomes and was well tolerated with a favorable safety profile. Trial Registration: ClinicalTrials.gov (identifier: NCT03635580). URL: https://clinicaltrials.gov/ct2/show/NCT03635580.

Indexed as

Human Growth HormoneBody HeightChild, PreschoolChinaGrowth DisordersHumansRecombinant ProteinsHuman Growth HormoneRecombinant ProteinsChinaefficacyidiopathic short staturerhGHsafety

Identifiers

PMID35573994
PMCPMC9102803

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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.