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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

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

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:
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
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