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Study of Effect of Tegaserod on Small and Large Bowel Transit by Scintigraphic Method

Primary Purpose

Constipation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tegaserod

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation (idiopathic)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

History of functional constipation as proposed by the Rome II Criteria and the usual frequency of spontaneous bowel motion must be equal or less than 2 times /week.
An endoscopic/radiologic bowel evaluation (colonoscopic examination and/or a sigmoidoscopy + barium enema) is required in patients older than 40 years. This evaluation must have been performed within the past 5 years. In addition, there should not be history or evidence of weight loss, anemia or rectal bleeding since the evaluation was performed.

Note: For patients who require these procedures, these tests should be performed after the patient has signed informed consent and at least 7 days PRIOR to the start of the diaries (washout period). The 7-day window is to allow the patient to recuperate prior to collecting baseline data.

A copy of the report should be placed in the patient source document.

Patients who are able to communicate well with the investigator and to comply with the requirements for the entire study, including the withdrawal period.
Patients who provide written informed consent before participating in the study after being given a full description of the study.

Exclusion Criteria:

Medications known to affect gastrointestinal transit before 1 week of the treatment phase of the study.
With clinical evidence (including physical exam, vital signs, ECG, laboratory tests) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematology, endocrine or metabolic disorders, neurologic disease, or of any disease that may interfere with the patient successfully completing the study.
Existence of surgical or medical conditions which interfere with the absorption, distribution, metabolism and excretion of the study medication.
With hypo or hyper thyroidism (clinically significant abnormal TSH level at screening).
With symptoms of a significant clinical illness in the two weeks preceding baseline.
With other relevant intercurrent medical condition that may interfere with the objectives of the study.
Women who are pregnant or breast-feeding.
With evidence or history of drug or alcohol abuse within the past 12 months.
Who received another investigational drug within the 30 days prior to entry in the study.

Sites / Locations

Caritas Medical CentreRecruiting
Princess Margaret HospitalRecruiting
Yan Chai HospitalRecruiting

Outcomes

Primary Outcome Measures

Small and large bowel transit time

Secondary Outcome Measures

Full Information

NCT ID

NCT00563615

First Posted

November 21, 2007

Last Updated

July 6, 2010

Sponsor

Hospital Authority, Hong Kong

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00563615

Brief Title

Study of Effect of Tegaserod on Small and Large Bowel Transit by Scintigraphic Method

Official Title

Study of Effect of Tegaserod on Small and Large Bowel Transit by Scintigraphic Method

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Authority, Hong Kong

Collaborators

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Functional constipation is a common problem in Hong Kong. In a recent telephone survey, the prevalence of constipation as defined by Rome II criteria was 14%. Apart from organic, metabolic, neurological and drug induced causes, constipation most often arises from 2 disorders of colorectal motility: slow transit constipation or pelvic floor dysfunction or both. In the position statement from the American Gastroenterological Association , colon transit study was recommended to differentiate slow transit constipation from pelvic floor dysfunction. The management algorithm for normal transit and slow transit constipation was different and surgery should be considered for patients with slow transit constipation. In a recent paper by Bonapace , scintigraphy could be used to study both gastric, small bowel and large bowel transit time. The clinical diagnosis was changed in 51% of cases of constipation after scintigraphy and patient management such as adding a prokinetic agent, referral to biofeedback center, decision on surgery was affected in 64% of cases. Tegaserod is a recently approved prokinetic agent to be marketed in Hong Kong for the management of patients with constipation predominant irritable bowel syndrome (C-IBS). In a paper from Mayo clinic based on scintigraphic examination, tegaserod 2mg bd accelerates orocaecal transit in C-IBS patients. However studies in functional constipation basing on tegaserod 6 mg twice daily has not been published yet. Therefore, the Gastroenterology team and nuclear medicine teams of Princess Margaret Hospital, Gastroenterology teams of Caritas Medical Center and Yan Chai Hospital decide to study small and large bowel transit in functional constipation patients by scintigraphy. The efficacy of tegaserod in improving bowel transit is also examined in this randomized double blind placebo controlled study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

Keywords

Constipation (idiopathic)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tegaserod

Primary Outcome Measure Information:

Title

Small and large bowel transit time

Time Frame

2 weeks after treatment

10. Eligibility

Sex

All

Eligibility Criteria

Inclusion Criteria: History of functional constipation as proposed by the Rome II Criteria and the usual frequency of spontaneous bowel motion must be equal or less than 2 times /week. An endoscopic/radiologic bowel evaluation (colonoscopic examination and/or a sigmoidoscopy + barium enema) is required in patients older than 40 years. This evaluation must have been performed within the past 5 years. In addition, there should not be history or evidence of weight loss, anemia or rectal bleeding since the evaluation was performed. Note: For patients who require these procedures, these tests should be performed after the patient has signed informed consent and at least 7 days PRIOR to the start of the diaries (washout period). The 7-day window is to allow the patient to recuperate prior to collecting baseline data. A copy of the report should be placed in the patient source document. Patients who are able to communicate well with the investigator and to comply with the requirements for the entire study, including the withdrawal period. Patients who provide written informed consent before participating in the study after being given a full description of the study. Exclusion Criteria: Medications known to affect gastrointestinal transit before 1 week of the treatment phase of the study. With clinical evidence (including physical exam, vital signs, ECG, laboratory tests) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematology, endocrine or metabolic disorders, neurologic disease, or of any disease that may interfere with the patient successfully completing the study. Existence of surgical or medical conditions which interfere with the absorption, distribution, metabolism and excretion of the study medication. With hypo or hyper thyroidism (clinically significant abnormal TSH level at screening). With symptoms of a significant clinical illness in the two weeks preceding baseline. With other relevant intercurrent medical condition that may interfere with the objectives of the study. Women who are pregnant or breast-feeding. With evidence or history of drug or alcohol abuse within the past 12 months. Who received another investigational drug within the 30 days prior to entry in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ambrose CP Kwan, Dr

Phone

(852) 2990 1111

argylest@netvigator.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ambrose CP Kwan, Dr

Organizational Affiliation

Department of Medicine and Geriatrics, Unit A, Princess Margaret Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Caritas Medical Centre

City

Hong Kong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yat Wah Yeung, Dr

Facility Name

Princess Margaret Hospital

City

Hong Kong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

King Sun Chu, Dr

First Name & Middle Initial & Last Name & Degree

Ka Man Ng, Dr

First Name & Middle Initial & Last Name & Degree

Wing Hang Wong, Dr

First Name & Middle Initial & Last Name & Degree

Hon Yeun, Dr

Facility Name

Yan Chai Hospital

City

Hong Kong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wai Keung Kwan, Dr

12. IPD Sharing Statement

Learn more about this trial

Study of Effect of Tegaserod on Small and Large Bowel Transit by Scintigraphic Method

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