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Report for Clinical Trial NCT01669811

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis

This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

NCT01669811 Refractory Reflux Esophagitis
MeSH:Gastroesophageal Reflux Esophagitis Esophagitis, Peptic
HPO:Esophagitis Gastroesophageal reflux

2 Interventions

Name: Esomeprazole (D961H) twice daily

Description: One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
Type: Drug
Group Labels: 1

D961H 20mg twice daily

Name: Esomeprazole (D961H) once daily

Description: One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening
Type: Drug
Group Labels: 1

D961H 20mg once daily


Primary Outcomes

Description: Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification

Measure: Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification

Time: 8 Weeks

Secondary Outcomes

Description: Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 4 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification

Measure: Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4

Time: 4 Weeks

Description: Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.

Measure: Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4

Time: 4 Weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 D961H

A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis. --- D961H ---

A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis. --- D961H --- --- D961H ---

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification. --- D961H ---

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification. --- D961H --- --- D961H ---

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus) This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification. --- D961H --- --- D961H --- --- D961H ---

Refractory Reflux Esophagitis Gastroesophageal Reflux Esophagitis Esophagitis, Peptic A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis --- D961H ---

Refractory Reflux Esophagitis Gastroesophageal Reflux Esophagitis Esophagitis, Peptic A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis --- 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