Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access
Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc
Journal website https://gr.elmerpub.com

Original Article

Volume 19, Number 4, August 2026, pages 233-242

Safety and Efficacy of Fixed-Dose Pantoprazole and Sustained Release Levosulpiride for Short-Term Management of Gastroesophageal Reflux Disease

Figures

↓  Figure 1. Study design.
Figure 1.
↓  Figure 2. Patient disposition.
Figure 2.
↓  Figure 3. Change in Frequency Scale for the Symptoms of GERD Scale from baseline.
Figure 3.
↓  Figure 4. Acid reflux-related symptoms of Frequency Scale for the Symptoms of GERD.
Figure 4.
↓  Figure 5. Dyspeptic symptoms of Frequency Scale for the Symptoms of GERD Scale from baseline.
Figure 5.
↓  Figure 6. Change in severity of symptoms of GERD by Likert Scale.
Figure 6.
↓  Figure 7. Change in Clinical Global Impression of Improvement (CGI-I).
Figure 7.
↓  Figure 8. Change in Clinical Global Impression of Severity (CGI-S).
Figure 8.

Tables

↓  Table 1. Incidence of Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
 
System organ class: preferred termFDC of pantoprazole sodium + levosulpiride SR capsules (N = 509)Severity of adverse events
MildModerate
FDC: fixed-dose combination; SR: sustained release.
Abdominal pain1 (0.2%)1 (0.2%)0
Constipation1 (0.2%)1 (0.2%)0
Diarrhea3 (0.6%)2 (0.4%)1 (0.2%)
Nausea2 (0.4%)2 (0.4%)0
Pyrexia5 (1%)1 (0.2%)4 (0.8%)
Nasopharyngitis1 (0.2%)1 (0.2%)0
Rhinitis2 (0.4%)02 (0.4%)
Urinary tract infection3 (0.6%)03 (0.6%)
Blood prolactin increased50 (9.8%)10 (2%)40 (7.9%)
Dizziness1 (0.2%)1 (0.2%)0
Headache6 (1.2%)4 (0.8%)2 (0.4%)
Testicular pain1 (0.2%)1 (0.2%)0
Cough1 (0.2%)01 (0.2%)
Oropharyngeal pain1 (0.2%)1 (0.2%)0
Rhinitis allergic1 (0.2%)1 (0.2%)0

 

↓  Table 2. Change in Modified Simpson Angus Scale (MSAS)
 
Statistics summaryVisit 2 (day 0) (N = 509)Visit 3 (day 14 ± 2) (N = 507)Visit 4 (day 28 ± 2) (N = 492)
Normal508 (99.8%)507 (100%)492 (100%)
Minimal degree of movement disorder1 (0.2%)0 (0.0%)0 (0.0%)
Clinically significant degree of movement disorder0 (0.0%)0 (0.0%)0 (0.0%)
Severe degree of movement disorder is present0 (0.0%)0 (0.0%)0 (0.0%)