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Methods: In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole 20 mg + domperidone 30 mg) or group 2 (omeprazole 20 mg) in an equal ratio; 2 capsules daily in... more
Methods:
In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole 20 mg + domperidone 30 mg) or group 2 (omeprazole 20 mg) in an equal ratio; 2 capsules daily in the morning were administered for 8 weeks.
Results:
Sixty patients were enrolled. Esophagitis reversal was observed in 92% patients in group 1 vs 65.2% in group 2. Approximately, 83.3% patients in group 1 vs 43.3% patients in group 2 demonstrated full cupping of reflux symptoms at 8 weeks. Combined therapy resulted in significantly longer period of heartburn-free days (23 vs 12 days on omeprazole). There were no safety concerns.
Conclusions:
Omeprazole-domperidone combination was more effective than omeprazole alone in providing complete cupping of reflux symptoms and healing of esophagitis in patients with GERD. Both the treatments were well tolerated with few reports of adverse events.
Trial registration:
This trial is registered with http://clinicaltrials.gov, number NCT02140073.
In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole 20 mg + domperidone 30 mg) or group 2 (omeprazole 20 mg) in an equal ratio; 2 capsules daily in the morning were administered for 8 weeks.
Results:
Sixty patients were enrolled. Esophagitis reversal was observed in 92% patients in group 1 vs 65.2% in group 2. Approximately, 83.3% patients in group 1 vs 43.3% patients in group 2 demonstrated full cupping of reflux symptoms at 8 weeks. Combined therapy resulted in significantly longer period of heartburn-free days (23 vs 12 days on omeprazole). There were no safety concerns.
Conclusions:
Omeprazole-domperidone combination was more effective than omeprazole alone in providing complete cupping of reflux symptoms and healing of esophagitis in patients with GERD. Both the treatments were well tolerated with few reports of adverse events.
Trial registration:
This trial is registered with http://clinicaltrials.gov, number NCT02140073.
Research Interests:
Background: Mesalazine as the treatment standard for ulcerative colitis can be applied in different galenical preparations. Aim: A novel formulation of mesalazine pellets with delayed and prolonged release characteristics was compared... more
Background: Mesalazine as the treatment standard for ulcerative colitis can be applied in
different galenical preparations. Aim: A novel formulation of mesalazine pellets with delayed
and prolonged release characteristics was compared with conventional Eudragit L-coated
tablets. Furthermore, the effect of mesalazine dose escalation on nonresponders was
evaluated in both treatment groups. Methods: A total of 233 patients with mild to moderately
active ulcerative colitis were randomized to receive either mesalazine (1.5 g/day in three ...
different galenical preparations. Aim: A novel formulation of mesalazine pellets with delayed
and prolonged release characteristics was compared with conventional Eudragit L-coated
tablets. Furthermore, the effect of mesalazine dose escalation on nonresponders was
evaluated in both treatment groups. Methods: A total of 233 patients with mild to moderately
active ulcerative colitis were randomized to receive either mesalazine (1.5 g/day in three ...
Research Interests:
BACKGROUND & AIMS: Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these... more
BACKGROUND & AIMS: Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these variations. METHODS: We performed a 10-week, randomized, double-blind, placebo-controlled study of 281 patients with mildly to moderately active UC, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) sigmoidoscopy score≥ 2, that evaluated the efficacy of delayed-release ...
Research Interests:
Research Interests:
Background: High concentration mesalazine formulations are more convenient than conventional low concentration formulations for the treatment of ulcerative colitis (UC). Aim: To compare the efficacy and safety of 1600 mg and 400 mg tablet... more
Background: High concentration mesalazine formulations are more convenient than
conventional low concentration formulations for the treatment of ulcerative colitis
(UC).
Aim: To compare the efficacy and safety of 1600 mg and 400 mg tablet mesalazine
formulations.
Methods: Patients with mild-to-moderate active UC (Mayo Clinic Score >5; N=817)
were randomised to 3.2 g of oral mesalazine, administered as two 1600 mg tablets
once, or four 400 mg tablets twice daily. We hypothesised that treatment with the
1600 mg tablet was non-inferior (within a 10% margin) to the 400 mg tablet for
induction of clinical and endoscopic remission at week 8. Open-label treatment with
the 1600 mg tablet continued for 26-30 weeks based on induction response. Predictors
of treatment response were also explored.
Results: At week 8, remission occurred in 22.4% and 24.6% of patients receiving
the 1600 mg and 400 mg tablets, respectively (absolute difference 2.2%, 95% CI:
8.1% to 3.8%, non-inferiority P=.005). Endoscopic and histopathologic disease
activity, leucocyte concentration and age were significantly associated with clinical
remission (P=.022, .042, .014 and .023, respectively). At week 38, 43.9% (296/675)
of patients who continued treatment with the 1600 mg formulation were in remission,
including 70.3% (142/202) of patients who received a reduced dose of mesalazine
(1.6 g/d). The overall incidence of serious adverse events was low.
Conclusions: Induction therapy with 3.2 mg mesalazine using two 1600 mg tablets
once-daily was statistically and clinically non-inferior to a twice-daily regimen using
four 400 mg tablets (NCT01903252).
conventional low concentration formulations for the treatment of ulcerative colitis
(UC).
Aim: To compare the efficacy and safety of 1600 mg and 400 mg tablet mesalazine
formulations.
Methods: Patients with mild-to-moderate active UC (Mayo Clinic Score >5; N=817)
were randomised to 3.2 g of oral mesalazine, administered as two 1600 mg tablets
once, or four 400 mg tablets twice daily. We hypothesised that treatment with the
1600 mg tablet was non-inferior (within a 10% margin) to the 400 mg tablet for
induction of clinical and endoscopic remission at week 8. Open-label treatment with
the 1600 mg tablet continued for 26-30 weeks based on induction response. Predictors
of treatment response were also explored.
Results: At week 8, remission occurred in 22.4% and 24.6% of patients receiving
the 1600 mg and 400 mg tablets, respectively (absolute difference 2.2%, 95% CI:
8.1% to 3.8%, non-inferiority P=.005). Endoscopic and histopathologic disease
activity, leucocyte concentration and age were significantly associated with clinical
remission (P=.022, .042, .014 and .023, respectively). At week 38, 43.9% (296/675)
of patients who continued treatment with the 1600 mg formulation were in remission,
including 70.3% (142/202) of patients who received a reduced dose of mesalazine
(1.6 g/d). The overall incidence of serious adverse events was low.
Conclusions: Induction therapy with 3.2 mg mesalazine using two 1600 mg tablets
once-daily was statistically and clinically non-inferior to a twice-daily regimen using
four 400 mg tablets (NCT01903252).
Research Interests:
Aim: To compare the efficacy and safety of omeprazole-domperidone combination vs omeprazole monotherapy in gastroesophageal reflux disease (GERD). Methods : In a comparative, randomized controlled, phase 4 study, outpatients with GERD... more
Aim: To compare the efficacy and safety of omeprazole-domperidone combination vs omeprazole monotherapy in gastroesophageal reflux
disease (GERD).
Methods : In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole
20 mg + domperidone 30 mg) or group 2 (omeprazole 20 mg) in an equal ratio; 2 capsules daily in the morning were administered for
8 weeks.
Results : Sixty patients were enrolled. Esophagitis reversal was observed in 92% patients in group 1 vs 65.2% in group 2. Approximately,
83.3% patients in group 1 vs 43.3% patients in group 2 demonstrated full cupping of reflux symptoms at 8 weeks. Combined therapy resulted
in significantly longer period of heartburn-free days (23 vs 12 days on omeprazole). There were no safety concerns.
Concl usions: Omeprazole-domperidone combination was more effective than omeprazole alone in providing complete cupping of
reflux symptoms and healing of esophagitis in patients with GERD. Both the treatments were well tolerated with few reports of adverse
events.
Trial registrat ion: This trial is registered with http://clinicaltrials.gov, number NCT02140073.
Keywords : Omeprazole, domperidone, gastroesophageal reflux, visual analogue pain scale.
disease (GERD).
Methods : In a comparative, randomized controlled, phase 4 study, outpatients with GERD were randomly allocated to either group 1 (omeprazole
20 mg + domperidone 30 mg) or group 2 (omeprazole 20 mg) in an equal ratio; 2 capsules daily in the morning were administered for
8 weeks.
Results : Sixty patients were enrolled. Esophagitis reversal was observed in 92% patients in group 1 vs 65.2% in group 2. Approximately,
83.3% patients in group 1 vs 43.3% patients in group 2 demonstrated full cupping of reflux symptoms at 8 weeks. Combined therapy resulted
in significantly longer period of heartburn-free days (23 vs 12 days on omeprazole). There were no safety concerns.
Concl usions: Omeprazole-domperidone combination was more effective than omeprazole alone in providing complete cupping of
reflux symptoms and healing of esophagitis in patients with GERD. Both the treatments were well tolerated with few reports of adverse
events.
Trial registrat ion: This trial is registered with http://clinicaltrials.gov, number NCT02140073.
Keywords : Omeprazole, domperidone, gastroesophageal reflux, visual analogue pain scale.
Research Interests:
BACKGROUND & AIMS: Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these... more
BACKGROUND & AIMS: Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these variations. METHODS: We performed a 10-week, randomized, double-blind, placebo-controlled study of 281 patients with mildly to moderately active UC, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) sigmoidoscopy score≥ 2, that evaluated the efficacy of delayed-release ...