Abstract:
BACKGROUND:The tablet formulation of sodium phosphate (NaP) is a prescription osmotic purgative that has been marketed since 2001. The use of NaP tablets in patients with constipation has not been studied previously. OBJECTIVE:This study assessed the tolerability and efficacy of 28 days of therapy with NaP tablets (1.5 g NaP/tablet) in patients with chronic constipation. METHODS:Adults with functional constipation or constipation-predominant irritable bowel syndrome and Z-3 spontaneous bowel movements (BMs) during the 7-day screening/baseline period were eligible for this open-label, dose-ranging study. Patients were randomized to receive starting doses of 4 NaP tablets (group A) or 8 NaP tablets (group B) each morning for 28 days. After a minimum of 48 hours, the NaP dose could be titrated upward (in the case of no BM or no relief of symptoms) or downward (in the case of a predefined excess laxative response) by 2 tablets/d to a minimum of 2 tablets/d or a maximum of 12 tablets/d. Patients kept a diary of their BMs and gastrointestinal symptoms. A serum chemistry panel was obtained weekly. The primary end points were the constipation response (based on the change from baseline in weekly number of BMs) and the global sense response (based on daily scores for the patient's overall sense of change in their bowel problems). RESULTS:At randomization, there were 18 patients in group A and 25 in group B. Of these, 40 patients (16 group A, 24 group B) had > or 7 days of diary information while taking study treatment and were evaluable for efficacy. The constipation response rate was 100% in group A and 95.8% in group B, and the respective global sense response rates were 68.8% and 79.2%. Four patients in group B withdrew due to adverse events, none of which were serious. Five patients had occasional hypokalemia that required no treatment. Changes from baseline in serum concentrations of calcium, inorganic phosphorus, and potassium were not clinically significant and did not require treatment. CONCLUSIONS:In this small study, NaP tablets taken daily were generally well tolerated (particularly in the low-dose group) and produced prompt relief of constipation--generally within the first week of treatment--that was sustained over the 28-day treatment period. A reasonable starting dose appears to be 2 to 4 tablets (3-6 g NaP) daily.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Medoff J,Katz S,Malik P,Pambianco D,Pruitt R,Poulos J,Rank J,Rose Mdoi
10.1016/j.clinthera.2004.09.007subject
Has Abstractpub_date
2004-09-01 00:00:00pages
1479-91issue
9eissn
0149-2918issn
1879-114Xpii
S0149-2918(04)80294-7journal_volume
26pub_type
临床试验,杂志文章,随机对照试验abstract::Several patients treated with amoxapine (in dosages ranging from 50 to 300 mg/day) had excellent initial responses followed by relapse unresponsive to dose adjustment, suggesting pharmacological tolerance to its antidepressant effect. ...
journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
pub_type: 杂志文章
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(03)80103-0
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journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1997-09-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(97)80130-0
更新日期:1997-05-01 00:00:00
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pub_type: 临床试验,杂志文章,多中心研究
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pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
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journal_title:Clinical therapeutics
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doi:
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pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:1995-03-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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