A Glass of Water Immediately Increases Gastric pH in Healthy Subjects

Karamanolis, George; Theofanidou, Ioanna; Yiasemidou, Marina; Giannoulis, Evangelos; Triantafyllou, Konstantinos; Ladas, Spiros D.

doi:10.1007/s10620-008-0301-3

Cited by 20 publications

(15 citation statements)

References 19 publications

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“…Water can provide immediate symptom relief of heartburn; therefore, the ingestion of water during the intake of randomized study medication (suspension and capsule) may have affected the patients’ heartburn severity scores as well as the perceived speed of onset for each medication. One study demonstrated that a glass of water (200mL) increased gastric pH >4 in 10/12 healthy subjects after 1 minute, whereas the median time to pH >4 was 171 minutes for omeprazole[ 31 ].…”

Section: Discussionmentioning

confidence: 99%

Challenges of Correlating pH Change with Relief of Clinical Symptoms in Gastro Esophageal Reflux Disease: A Phase III, Randomized Study of Zegerid versus Losec

et al. 2015

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BackgroundZegerid (on demand immediate-release omeprazole and sodium bicarbonate combination therapy) has demonstrated earlier absorption and more rapid pH change compared with Losec (standard enteric coated omeprazole), suggesting more rapid clinical relief of heartburn. This Phase III, multicenter, double-blind, double-dummy, randomized study assessed the clinical superiority of Zegerid versus Losec for rapid relief of heartburn associated with gastro-esophageal reflux disease (GERD).MethodsPatients with a history of frequent (2 3 days/week) uncomplicated GERD, were randomized to receive Zegerid (20mg) or Losec (20mg) with corresponding placebo. Study medication was self-administered on the first episode of heartburn, and could be taken for up to 3 days within a 14 day study period. Heartburn severity was self assessed up to 180 minutes post dose (9 point Likert scale). Primary endpoint was median time to sustained response (≥3 point reduction in heartburn severity for ≥45 minutes).ResultsOf patients randomized to Zegerid (N=122) or Losec (N=117), 228/239 had recorded ≥1 evaluable heartburn episodes and were included in the modified intent-to-treat population. No significant between-group differences were observed for median time to sustained response (60.0 vs. 52.2 minutes, Zegerid [N=117] and Losec [N=111], respectively), sustained partial response (both, 37.5 minutes) and sustained total relief (both, 105 minutes). Significantly more patients treated with Zegerid reached sustained total relief within 0–30 minutes post dose in all analysis sets (p<0.05). Both treatments were well tolerated and did not raise any safety concerns.ConclusionsSuperiority of Zegerid over Losec for rapid heartburn relief was not demonstrated; both treatments were equally effective however the rapid onset of action of Losec was unexpected. Factors, including aspects of study design may have contributed to this. This study supports previously reported difficulty in correlating intra-gastric pH change with clinical effect in GERD therapy, highlighting the significance of several technical considerations for studies of this type.Trial registrationClinicalTrials.gov NCT01493089

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Section: Discussionmentioning

confidence: 99%

Challenges of Correlating pH Change with Relief of Clinical Symptoms in Gastro Esophageal Reflux Disease: A Phase III, Randomized Study of Zegerid versus Losec

et al. 2015

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“…9 This could be due to gastric absorption of dissolved ibuprofen, as has been demonstrated in rats with a ligated pylorus, 61 or because of faster gastric emptying of the solution, 62 as initial emptying of water from the stomach is faster than that of radiolabeled gelatin or HPMC capsules of ibuprofen, 63 which in turn leads to faster absorption. 64 Further, it is possible that the gastric pH is temporarily elevated because of the salt dissolution as well as to the coadministration of water, 65 and thus accelerates the gastric emptying. 66 As Simcyp Simulator R in the current version does not account for gastric absorption and assumes GET is the same for solutions, solutions with precipitation and immediate-release solid dosage forms (assuming immediate disintegration of the dosage form into fine particles), it was to be expected that no sensitivity to gastric solubility would be detected in the sensitivity analysis.…”

Section: Sensitivity Analysis: Gastric Solubility and Getmentioning

confidence: 99%

Use of Physiologically Based Pharmacokinetic Models Coupled with Pharmacodynamic Models to Assess the Clinical Relevance of Current Bioequivalence Criteria for Generic Drug Products Containing Ibuprofen

Cristofoletti

Dressman

2014

Journal of Pharmaceutical Sciences

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“…In contrast, the short-term, temporary gastric acid reflux is mainly attributed to the mild GERD transient heartburn. Water and H2RAs increase the intragastric pH immediately, whereas PPIs increase it slowly [22]. However, PPIs have a more prolonged effect than H2RAs [3].…”

Section: Discussionmentioning

confidence: 99%

Early effect on intragastric pH of oral administration of rabeprazole with mosapride compared with rabeprazole alone

Iida¹,

Kaai²,

Inoh

et al. 2017

aog

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BackgroundAn ideal medication for acid-related diseases would offer prompt stopping of blood flow as well as efficient symptom resolution. The aim of this study was to investigate the gastric acid suppression potency of a single oral dose of rabeprazole alone, compared with administration of rabeprazole plus mosapride.MethodsTwelve male volunteers, Helicobacter pylori (H. pylori)-negative, participated in this randomized, three-way crossover study. After a single oral administration of rabeprazole, rabeprazole with mosapride, or rabeprazole administered 1 h after mosapride, we monitored their intragastric pH constantly for 6 h. A 7-day washout period was allowed between each administration.ResultsThe median 6-h intragastric pH after the administration of rabeprazole 1 h after mosapride was 4.41±1.22 (mean±s.d.), significantly higher than after rabeprazole alone 3.45±1.33, P=0.0376). There was no significant difference between the median 6-h pH after the administration of rabeprazole plus mosapride and that after rabeprazole alone (3.81±0.98 vs. 3.45±1.33, respectively; P=0.0927).ConclusionAn oral dose of rabeprazole administered 1 h after mosapride increased the intragastric pH more rapidly than rabeprazole alone, in healthy, male, H. pylori-negative volunteers.

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A Glass of Water Immediately Increases Gastric pH in Healthy Subjects

Abstract: Water and antacid immediately increased gastric pH, while PPIs showed a delayed but prolonged effect compared to ranitidine.

Cited by 20 publications

References 19 publications

Challenges of Correlating pH Change with Relief of Clinical Symptoms in Gastro Esophageal Reflux Disease: A Phase III, Randomized Study of Zegerid versus Losec

Challenges of Correlating pH Change with Relief of Clinical Symptoms in Gastro Esophageal Reflux Disease: A Phase III, Randomized Study of Zegerid versus Losec

Use of Physiologically Based Pharmacokinetic Models Coupled with Pharmacodynamic Models to Assess the Clinical Relevance of Current Bioequivalence Criteria for Generic Drug Products Containing Ibuprofen

Early effect on intragastric pH of oral administration of rabeprazole with mosapride compared with rabeprazole alone

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