SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03553563

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin

This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want.

NCT03553563 Reflux Esophagitis Gastric Ulcer Duodenal Ulcer
MeSH: Ulcer Gastroesophageal Reflux Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic
HPO: Duodenal ulcer Esophagitis Gastric ulcer Gastroesophageal reflux

2 Interventions

Name: D961H capsule 10mg

Description: All Groups can select either capsule or sachet during the study.

Type: Drug

Group1 Group2 Group3 Group4

Name: D961H sachet 10mg

Description: All Groups can select either capsule or sachet during the study.

Type: Drug

Group1 Group2 Group3 Group4


Primary Outcomes

Description: Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all subjects by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.

Measure: Presence/absence of reflux esophagitis relapse

Time: 8 to 32 weeks

Description: Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all subjects.

Measure: Adverse events during reflux esophagitis maintenance therapy

Time: 8 to 32 weeks

Description: Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all subjects by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.

Measure: Presence/absence of gastric ulcer or duodenal ulcer recurrence

Time: 0 to 32 weeks

Description: Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 32 weeks for all subjects.

Measure: Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy

Time: 0 to 32 weeks

Secondary Outcomes

Description: Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (reflux esophagitis-related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.

Measure: Presence/absence of reflux esophagitis relapse

Time: 8 to 52 weeks

Description: Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 52 weeks for subjects who continued the study treatment after Week 32.

Measure: Adverse events during reflux esophagitis maintenance therapy

Time: 8 to 52 weeks

Description: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.

Measure: Presence/absence of gastric ulcer or duodenal ulcer recurrence

Time: 0 to 52 weeks

Description: Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 52 weeks for subjects who continued the study treatment after Week 32.

Measure: Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy

Time: 0 to 52 weeks

Purpose: Prevention

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 D961H

An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin. --- D961H ---

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. --- D961H ---

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. --- D961H --- --- D961H ---

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. --- D961H --- --- D961H --- --- D961H ---

Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. --- D961H ---

Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. --- D961H ---

Number of Subjects Maintenance therapy for healed reflux esophagitis study part: - Group1:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg ), Maintenance phase, n=5 to 10 - Group2:aged 1 to 14 years (weight more than equal 20 kg), Maintenance phase, n=10 to 20 Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: - Group3:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg), n=5 to 10 at Week 0 - Group4:aged 1 to 14 years (weight more than equal 20 kg), n=10 to 20 at Week 0 All subjects have a D961H administration for 32 or 52 weeks. --- D961H ---



HPO Nodes


HPO:
Duodenal ulcer
Genes 2
ARID1B PLG
Esophagitis
Genes 25
SLC6A5 CDKN1A TGFB2 CDKN1B GPHN TGFB3 CDKN2B TGFBR1 SLC2A10 CDKN2C TGFBR2 TRAPPC11 TCF4 ATP7A PSPH CARMIL2 ATAD1 ADAMTS2 PHGDH GLRA1 GLRB RPL11 SMAD3 FERMT1 MEN1
Gastric ulcer
Genes 4
ARID1B ERGIC1 CISD2 WFS1
Gastroesophageal reflux
Genes 258
GABRB2 GPHN GABRD SOX5 PIGN UBA5 ATP6V1A ASXL1 AARS ABCA3 AMER1 HIVEP2 SAMD9 ATP7A WWOX ATRX STAG1 KIF1A MAP1B RTEL1 MYO9A ORC6 NEXMIF SMC1A HLA-DRB1 PIEZO1 IQSEC2 KIAA0586 KIAA0319L HDAC8 CPLX1 SLC5A7 FGFRL1 DHDDS CHAT IRF5 SLC46A1 EXT2 NUP62 POGZ PSPH TSPYL1 SSR4 RREB1 WNK1 ADAR DDC MECP2 TRIP4 DDOST PHGDH HNRNPH2 MEIS2 STN1 TBC1D24 HIRA FBXL4 TWIST1 SYNGAP1 SHROOM4 SLC2A10 CDKL5 FCSK LONP1 TRMT10C FBN1 KCNA2 SALL1 STXBP1 SFTPA2 RNF125 TMTC3 BRAF KCNB1 NRXN1 SYNJ1 NALCN TECPR2 KLHL7 WASHC5 CCDC47 DHCR7 GLRA1 GLRB SCN3A MID1 UFD1 ARNT2 VAMP1 SLC35A2 CLTC SCN8A RETREG1 SCN9A HRAS ABCD4 CTHRC1 MYMK SMG9 PYCR1 ALDH18A1 KMT2A SYT1 SFTPA1 FGF12 ATP11A CCR6 MCEE FGFR3 TAF1 CAMTA1 DNM1 PHOX2B MAP3K7 LTBP4 NONO NIPBL SLC9A6 MED12 FOXG1 TBX1 SEC23A GP1BB RAD21 NPHS1 CACNA1A SLC25A24 FLII FLNA TCF4 MAGEL2 TBX4 CCDC22 COL13A1 DEAF1 FMR1 NEDD4L COMT ARV1 RHBDF2 SLC25A4 ADAMTS2 CLIP2 SZT2 DSP SFTPC EBF3 PUF60 WHCR COG7 NSD2 PPM1D CAMK2B HCN1 NTRK2 RRM2B POLG CNTNAP1 KAT6A ASCC1 SLC19A2 KCNAB2 ARFGEF2 LAMA2 ELP1 NTNG1 BAZ1B FARSB PORCN TWNK CNKSR2 MUC5B CHD7 ZSWIM6 OCRL SYT2 CAV1 GRIN2D LBR RET RFC2 GABBR2 GTF2IRD1 SKI TYMP TERC CHAMP1 TERT SLC1A2 TFAP2A YWHAG GMNN JMJD1C SHANK3 SH2B1 LETM1 ARF1 CYFIP2 NECAP1 TRAK1 EEF1A2 MSR1 SLC6A3 ORC1 ORC4 MLXIPL LIMK1 PIEZO2 GTF2I PPP3CA ATP6 DPP9 SEC24C FAM13A ATAD1 ARVCF SMC3 SETD5 SLC18A3 ASCL1 SLC25A1 ARID2 NUS1 AP3B2 ASPA SLC6A5 PAK1 GEMIN4 EHMT1 MRPS34 FLCN LRP5 SLC13A5 CTBP1 PARN CCN2 PRKCSH ELN SNAP25 RERE CDC6 SEC63 POLG2 KAT6B ERMARD SNRPB PRDM16 CSPP1 AGRN TNXB TBL2 TOP3A AFF4 RPL10 RAI1 SEMA3E SON CHMP1A