SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01669811

Developed by Shray Alag, 2019.
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 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
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