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Report for Clinical Trial NCT02153398

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases

The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.

NCT02153398 Gastric Ulcer (GU) Duodenal Ulcer (DU) Anastomotic Ulcer (AU) Non-erosive Reflux Esophagitis Disease (NERD) Reflux Esophagitis (RE) Zollinger-Ellison Syndrome
MeSH: Zollinger-Ellison Syndrome Gastrinoma Gastroesophageal Reflux Esophagitis Stomach Ulcer Duodenal Ulcer Esophagitis, Peptic Ulcer
HPO: Duodenal ulcer Esophagitis Gastric ulcer Gastroesophageal reflux Zollinger-Ellison syndrome

3 Interventions

Name: D961H sachet 10 mg

Type: Drug

Group 1: D961H sachet 10 mg

Name: D961H capsule 10mg

Type: Drug

Group 2: D961H capsule 10mg Group 4: D961H capsule 10 mg

Name: D961H capsule 20 mg

Type: Drug

Group 3: D961H capsule 20 mg Group 5: D961H capsule 20 mg


Primary Outcomes

Description: The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Heartburn at Week 8 by Patient Diaries

Time: 8 weeks

Description: The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Epigastric Pain at Week 8 by Patient Diaries

Time: 8 weeks

Description: The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Time: 8 weeks

Description: The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.

Measure: Disappearance of Regurgitation at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Heartburn at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Epigastric Pain at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Time: 8 weeks

Description: The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.

Measure: Aggravation of Regurgitation at Week 8 by Patient Diaries

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Heartburn at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Epigastric Pain at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.

Measure: Disappearance of Regurgitation at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Heartburn at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Epigastric Pain at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators

Time: 8 weeks

Description: The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.

Measure: Aggravation of Regurgitation at Week 8 by Investigators

Time: 8 weeks

Secondary Outcomes

Measure: Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Measure: Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose

Time: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 D961H

An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases. --- D961H ---

An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases. --- D961H --- --- D961H ---

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome. --- D961H ---

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome. --- D961H --- --- D961H ---

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome. --- D961H --- --- D961H --- --- D961H ---



HPO Nodes


HPO:
Duodenal ulcer
Genes 5
PLG ARID1B PLA2G4A PLG PLG
Esophagitis
Genes 29
TGFBR1 CDKN2B GLRB CARMIL2 ADAMTS2 RPL11 GPHN CDKN2C SLC6A5 PGM3 PHGDH TRAPPC11 TCF4 CDKN1B FERMT1 TGFBR2 GLRA1 TCF4 TGFB2 MEN1 SLC2A10 CDKN1A TGFB3 MEN1 CDKN1B ATAD1 PSPH ATP7A SMAD3
Gastric ulcer
Genes 6
CISD2 ARID1B WFS1 PLA2G4A ERGIC1 CISD2
Gastroesophageal reflux
Genes 328
LETM1 TMTC3 MID1 DHDDS NUP62 NONO TBC1D24 SON BAZ1B FLNA EHMT1 ORC1 SCN8A KCNA2 GPHN NIPBL PORCN ATP11A MED12 RAI1 PARS2 CAMK2B ATRX TYMP IQSEC2 RFC2 ARF1 WASHC5 UBA5 RERE TERT KIF1A ATRX ZSWIM6 GABRA2 ORC4 DPP9 SLC19A2 DHCR7 FOXG1 ASCL1 TERC ATN1 YWHAG MYO9A AGRN TWNK STXBP1 TBX1 SLC18A3 GTF2IRD1 UBA5 NECAP1 LAMA2 SEC63 NEDD4L SMC3 SCN3A SMC3 MECP2 TRMT10C RPL10 ARNT2 LRP5 SFTPA2 HDAC8 MECP2 SLC2A10 FOXG1 GABRG2 MCEE ASXL1 SOX5 SETD5 PPM1D DDOST IRF5 DDC AMER1 FGFRL1 NUP214 CYFIP2 ORC6 GRIN2D STAC3 RPL10 GMNN HLA-DRB1 HIRA CCDC47 SEC23A CDKL5 DNM1 MLXIPL BRAF DEAF1 CLIP2 NRXN1 PUF60 FBXL4 NALCN SFTPA1 FARSB CTBP1 MAP3K7 TRIP4 ELN CLCN4 PAK1 PYCR1 EXT2 SMC1A FLCN SHANK3 SAMD9 SMC1A SYT1 KAT6B SMG9 MAP3K7 SLC25A4 LBR SSR4 PIEZO2 PSPH SLC1A2 TBL2 HLA-DRB1 ATP6 SNRPB RAI1 STXBP1 CCR6 TCF4 COG7 ADAR HDAC8 TSPYL1 ELN ARVCF TSPYL1 SEC24C ARID2 ELP1 FOXG1 STN1 PIGN SH2B1 NALCN JMJD1C SKI RTEL1 CDKL5 SHANK3 PIGN SLC6A3 FMR1 COMT SLC5A7 UFD1 NONO SHROOM4 TBX4 ATP7A SKI MSR1 ASPA POLG CAMTA1 LONP1 GTF2I SLC13A5 KIAA0586 KAT6A GLRB ABCD4 ASCC1 AARS1 NSD2 SNAP25 FCSK RET MUC5B MAGEL2 SLC6A5 POLG2 PRDM16 AP3B2 GABBR2 GEMIN4 SLC9A6 FGFR3 MRPS34 PIEZO1 TAF1 SCN9A POLG CCR6 ARV1 ALDH18A1 KMT2A COL13A1 CPLX1 GABRD GP1BB PARN SLC25A24 CACNA1B ADAMTS2 CAV1 HIVEP2 SFTPC ARFGEF2 IRF5 DDOST NPHS1 HNRNPH2 CHAT RHBDF2 CAV1 WHCR LIMK1 RNF125 TCF4 CTHRC1 RETREG1 RAI1 ASXL1 TRAK1 PHOX2B CDC6 SYNGAP1 SLC35A2 TFAP2A HCN1 CACNA1A POLG2 MEIS2 CCN2 DHCR7 NIPBL VAMP1 ADNP SMC1A MECP2 STAG1 TOP3A WWOX KMT2A NEXMIF MECP2 FBN1 GABRB2 PIGN KCNA2 CCN2 CNTNAP1 CHAMP1 SLC25A1 RERE PCGF2 RAD21 KLHL7 PGM3 ABCA3 NEXMIF SLC46A1 GABRA5 PPP3CA TCF4 KIAA0319L OCRL GLRA1 PACS1 FLNA RREB1 SLC6A3 ELP1 ATAD1 COL13A1 NUS1 CHMP1A RAD21 SZT2 FGF12 CCDC22 DSP FLII FAM13A TECPR2 SYT2 EEF1A2 ACTL6B RRM2B MAP1B SEMA3E CNKSR2 AFF4 POGZ NTRK2 NRXN1 SALL1 CNTNAP2 CHD7 PHGDH WNK1 ERMARD KCNAB2 KCNB1 EBF3 NTNG1 ATP6V1A MYMK HRAS SKI CLTC LTBP4 PRKCSH TBX1 CSPP1 ATRX TWIST1 POGZ ALDH18A1 SLC35A2 RRM2B SYNJ1 ATRX
Zollinger-Ellison syndrome
Genes 11
CDKN1B DAXX MEN1 CDKN1B CDKN2B MEN1 PIEZO2 CDKN2C MEN1 CDKN1A ATRX