Evaluating the effectiveness of nizatidine in the symptomatic relief of post-prandial heartburn / (Record no. 4082)

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control field 20210417130421.0
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Title Evaluating the effectiveness of nizatidine in the symptomatic relief of post-prandial heartburn /
520 3# - SUMMARY, ETC.
Summary, etc. Design: Phase IV, open label, non-comparative multicenter study<br/><br/>Setting: Private clinics of ACIDS study group physicians throughout the country whose patients satisfying the inclusion criteria were enrolled and treated from July 1999 to March 2000<br/><br/>Population: 403 patients presenting with post-prandial heartburn diagnosed as GERD (Gastroesophageal Reflux Disease)<br/><br/>Main Outcome Measures: Patients were assessed for the presence of signs and symptoms at baseline (time 0) and every 30 minutes thereafter until 3 1/2 hours (time 210) after intake of a single 150 mg capsule of Nizatidine. A severity of symptom rating scale was filled out during each assessment period and patients with at least one 30-minute observation period post-medication intake were included in the analysis. All adverse experiences were monitored and assessed for patients who took at least one dose of the medication. The first zero rating after baseline was considered as indication of relief of pain. Individual patient scores were averaged to obtain a meantime to relief after medication intake. Recurrence was noted if a patient reports a score of 1 or higher after a previous zero score. Analysis of adverse events was made on an intent-to-treat basis<br/><br/>Results: 85.6 percent of the 381 evaluable patients obtained complete relief. In the 255 patients who had complete observation data for the 1st visit, the complete relief rate is 91 percent. It took, on average 83.1 minutes to obtain complete relief. The mean symptom score at baseline was 2.36, with a median of 2 and a range of 1-4 indicating that most score at baseline was 2.36, with a median of 2 and a range of 1-4 indicating that most patients were in moderate to severe pain. Within the first 30 minutes, 19.6 percent of patients had been relieved of pain while about half (48.6 percent) were pain-free by the first hour. Four patients (1 percent of 403) had a recurrence of pain during the observation period and were considered as treatment failures. The mean time to recurrence was 112.5 minutes after obtaining pain relief, with a range of 90-150 minutes. Seven patients (1.7 percent of 403, 95 percent CI: 0.73.5) had at least one adverse experience, three of which could be drug-related<br/><br/>Conclusion: This study has shown that Nizatidine 150 mg PO single dose is an effective and safe acute treatment for post-prandial heartburn. Safety and compliance as well as effectiveness, should be important deciding factors in treatment choice for both patients and physicians.<br/><br/>Objectives<br/>To evaluate the effectiveness, tolerance and safety of Nizatidine 150 mg PO single dose in the symptomatic relief of post-prandial heartburn
580 ## - LINKING ENTRY COMPLEXITY NOTE
Linking entry complexity note <br/>The Filipino Family Physician, 2004 38 ( 4 ) p ages 103-108
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Nizatidine
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Heartburn
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Chua, F.
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Personal name Acuin, C.
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Personal name Alvero, J.
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Personal name Ng, M.
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Personal name Chan, C.
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Personal name Caballero, J.
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Personal name Orillo, F.
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Personal name Laigo, A.
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Personal name Nadala, T.
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Personal name Javelosa, M
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
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Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
    National Library of Medicine     DOH Central Library DOH Central Library Electronic Resource Section 04/17/2021   J000474 D0001J000474 04/17/2021 04/17/2021 Journal Article