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Method for treating irritable bowel syndrome by administration of chloride channel opener

a chloride channel and irritable bowel technology, which is applied in the field of prostaglandin compound, can solve the problems of abdominal discomfort, abdominal discomfort may also occur, and the drug is not known, and achieve the effect of significant effect on abdominal discomfor

Inactive Publication Date: 2013-08-22
SUCAMPO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about a new way to treat abdominal discomfort and gastrointestinal disorders. The inventor studied and found that a certain kind of compound can help to open up a certain kind of channel in the body that helps to relieve the discomfort. This invention is useful for treating conditions like IBS and FD.

Problems solved by technology

Various disorders may cause abdominal discomfort.
It is also known that abdominal discomfort may also occur as a side effect of drug, medication or surgical procedure.
However, it is not yet known as to the drug that may be used for safely and effectively treating abdominal discomfort.
Patients having functional gastrointestinal disorders often report abdominal discomfort.
No systematic method has been established for treating such disorder.
However, it is not known how chloride channel openers and / or prostaglandin compounds act on abdominal discomfort, or the functional gastrointestinal disorders.

Method used

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  • Method for treating irritable bowel syndrome by administration of chloride channel opener
  • Method for treating irritable bowel syndrome by administration of chloride channel opener
  • Method for treating irritable bowel syndrome by administration of chloride channel opener

Examples

Experimental program
Comparison scheme
Effect test

example 1

Methods

[0122]Patients with irritable bowel syndrome (IBS) were randomly allocated to the following two treatment groups.[0123]Group 1: Test substance (13,14-dihydro-15-keto-16,16-difluoro-PGE1) 48 μg total (24 μg / breakfast+24 μg / dinner)[0124]Group 2: Matching placebo (placebo / breakfast+placebo / dinner)

[0125]Each group underwent two weeks washout period and then began to administer oral test substance (capsules) or placebo (capsules) daily for 4 weeks. Test substance or placebo was taken two times a day (b.i.d) at breakfast with food and at least 8 ounces of water and at dinner with food and at least 8 ounces of water. Patients were asked to evaluate abdominal discomfort upon waking in the morning, using a 5-point scale (Score: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe) at 4 weeks after the initiation of the treatments.

Results

[0126]As shown in Table 1, test substance of this invention significantly improved the abdominal discomfort in the patients with IBS.

TABLE 1Effect of...

example 2

Methods

[0127]Patients with occasional constipation were randomly allocated to the following two treatment groups.[0128]Group 1: Test substance (13,14-dihydro-15-keto-16,16-difluoro-PGE1) 48 μg total (24 μg / breakfast+24 μg / dinner)[0129]Group 2: Matching placebo (placebo / breakfast+placebo / dinner)

[0130]Each group underwent two weeks washout period and then began to administer oral test substance (capsules) or placebo (capsules) daily for 4 weeks. During the washout period, the patient's bowel habit was documented to confirm the existence of constipation. Constipation is defined as, on average, less than three spontaneous bowel movements per week. All existing laxative medication was withdrawn at the start of the washout period and the patients were instructed not to change their diet or lifestyle during the study.

[0131]Test substance or placebo was taken orally for a total treatment period of 4 weeks; it was taken two times a day (b.i.d) at breakfast with food and at least 8 ounces of ...

example 3

Methods

[0134]Patients with irritable bowel syndrome (IBS) were randomly allocated to the following two treatment groups.[0135]Group 1: Test substance (13,14-dihydro-15-keto-16,16-difluoro-PGE1) 48 μg total (24 μg / breakfast+24 μg / dinner)[0136]Group 2: Matching placebo (placebo / breakfast+placebo / dinner)

[0137]Each group underwent two weeks washout period and then began to administer oral test substance (capsules) or placebo (capsules) daily for 4 weeks. Test substance or placebo was taken two times a day (b.i.d) at breakfast with food and at least 8 ounces of water and at dinner with food and at least 8 ounces of water. The patients were asked to evaluate abdominal bloating upon waking in the morning, using a 5-point scale (Score: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe) at 4 weeks after the initiation of the treatments.

Results

[0138]As shown in Table 3, test substance of this invention significantly improved the abdominal bloating in patients with IBS.

TABLE 3Effect of tes...

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PUM

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Abstract

A chloride channel opener, especially a prostaglandin compound, is used for the treatment of functional gastrointestinal disorders. The prostaglandin compound can be, for example, a 13,14-dihydro-15-keto-16,16-difluoro-prostaglandin E1 compound or 13,14-dihydro-15-keto-16,16-difluoro-18-methyl-prostaglandin E1 compound. The functional gastrointestinal disorders can be, for example, irritable bowel syndrome and / or functional dyspepsia. The treatment can include, for example, systemic administration 1-4 times per day or continuous administration of the compound in an amount of 0.01-100 μg per day.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This is a divisional of U.S. application Ser. No. 12 / 848,597 filed Aug. 2, 2010, which is a continuation of U.S. application Ser. No. 10 / 745,689 filed Dec. 29, 2003, which claims the benefit of provisional application Nos. 60 / 436,462 and 60 / 436,463 both filed Dec. 27, 2002, the contents of all of which are incorporated herein by reference in their entireties.TECHNICAL FIELD[0002]The present invention relates to a method for treating abdominal discomfort with a chloride channel opener, especially, a prostaglandin compound.[0003]Further, the present invention relates to a method for treating functional gastrointestinal disorders with a chloride channel opener, especially, a prostaglandin compound.BACKGROUND ART[0004]Abdominal indefinite complaint or abdominal discomfort is most often experienced in our daily lives, and it includes heartburn, nausea, emesis, anorexia, epigastric pain, abdominal bloating, chronic abdominal pain, abdominal dis...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07C57/56A61K31/557A61K31/5575A61P1/00A61P1/10
CPCA61K31/557C07C57/56A61K31/5575A61K31/5585A61P1/00A61P1/04A61P1/10A61P1/14A61P43/00
Inventor UENO, RYUJIKUNO, SACHIKO
Owner SUCAMPO
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