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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 Labels: 1

Group 1: D961H sachet 10 mg

Name: D961H capsule 10mg

Type: Drug
Group Labels: 2

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

Name: D961H capsule 20 mg

Type: Drug
Group Labels: 2

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:
HP:0002020: Gastroesophageal reflux
Genes 341
SMC1A WHCR COL13A1 ACTL6B CTHRC1 CSPP1 ATP7A PHOX2B PORCN ATRX SYNJ1 TRAK1 USP7 CDKL5 CLTC PRDM16 ABCD4 SMC3 RRM2B FGF12 PIGT VAMP1 KCNB1 CNTNAP2 FOXG1 SKI GLRA1 GLRB SKI MAP3K7 MECP2 KCNAB2 GABRD WNK1 CHD7 CTBP1 POLG SETD5 CTCF STN1 PPM1D SHROOM4 LIMK1 ATRX OCRL SLC46A1 TBX4 TBL2 CNTNAP1 ORC1 SHANK3 COG7 SLC1A2 TWNK ASXL1 SLC2A10 KCNA2 KIF1A ARFGEF2 ZSWIM6 SFTPA2 LBR DDC TWIST1 TAF1 MEIS2 ALDH18A1 FBXL4 RERE AMER1 HDAC8 AFF4 KIAA0586 ASCL1 TCF4 TBX1 RTEL1 PIEZO1 MRPS34 ARF1 NFIX KMT2A ATRX RHBDF2 ORC6 ELP1 TERC DDOST SLC6A5 RETREG1 SLC5A7 HNRNPH2 HIRA CLCN4 FLNA NEDD4L RAI1 AFF4 NSD2 CHAMP1 FAM13A SFTPC MID1 SLC35A2 SHANK3 RAD21 GABRB2 UFD1 STAG1 ARNT2 CLIP2 SLC19A2 SEC63 FGFRL1 SNRPB PARN RPL10 SMG9 NIPBL CACNA1A CAMTA1 PCGF2 NRXN1 SH2B1 NRXN1 MECP2 ATP6 DHCR7 LONP1 HRAS JMJD1C FCSK DNM1 ARID2 PAK1 BRAF POLG2 SLC35A2 RPL10 GABRA5 ATP11A CAMK2B TRMT10C ATAD1 CAV1 TBC1D24 SLC25A24 MAP3K7 PIGN DHCR7 TSPYL1 SMC3 DPP9 KCNA2 FBN1 SOX5 ASCC1 MAGEL2 EHMT1 POLG2 SEC24C ADNP NUP62 SMC1A MYO9A EEF1A2 NTNG1 RET SLC9A6 RNF125 FLII PIGN SSR4 HLA-DRB1 ERMARD SLC25A4 PRKCSH LRP5 SON SFTPA1 ATP6V1A ATN1 HCN1 POLG CACNA1B GRIN2D MAP1B TRAPPC12 TCF4 UBA5 IQSEC2 ATRX NEXMIF KIAA0319L NALCN CDKL5 CCR6 PIGN HIVEP2 SKI GMNN PPP3CA LTBP4 GEMIN4 EXT2 TOP3A STAG1 COMT MCEE LETM1 TERT TCF4 TSPYL1 DSP NUP214 LAMA2 NPHS1 SZT2 ADAMTS2 ARVCF GTF2I MYMK TMTC3 ASPA CCDC22 SLC1A4 IRF5 RERE SYNGAP1 TYMP ABCA3 DDOST KMT2A SAMD9 SEC23A SCN9A RAD21 ASXL1 FGFR3 ORC4 ELN YWHAG TBX1 PUF60 TFAP2A AP3B2 DHDDS NALCN AGRN UBA5 CNKSR2 MLXIPL SNAP25 COL13A1 RAI1 ADAT3 WDR26 ELN PYCR1 NONO KLHL7 NUS1 TECPR2 SLC25A1 TRIP4 ALDH18A1 CAV1 EXT2 CCDC47 ARV1 RREB1 STAC3 KAT6A POGZ PACS1 FLCN CCR6 RRM2B ELP1 GABRG2 BAZ1B CCN2 SLC6A3 PGM3 IRF5 WWOX RPL10 DEAF1 SCN8A EBF3 PSPH CPLX1 SLC13A5 HDAC8 HLA-DRB1 FOXG1 STXBP1 RAI1 WASHC5 SLC18A3 PARS2 GP1BB FLNA FARSB CYFIP2 AARS1 MUC5B GPHN STXBP1 RFC2 MECP2 NEXMIF NTRK2 NONO CHMP1A SYT2 SALL1 KAT6B MED12 ADAR POGZ SYT1 SCN3A PHGDH GABBR2 FMR1 SYT1 CDC6 PIEZO2 NIPBL SEMA3E MECP2 RERE CCN2 NECAP1 CHAT GTF2IRD1 SLC6A3 GABRA2 MSR1 SMC1A
Protein Mutations 1
D961H
SNP 0