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Status unknownNCT00563615Updated Jul 7, 2010

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

An interventional study of Tegaserod in Constipation, sponsored by Hospital Authority, Hong Kong. Status unknown at 3 sites in China. Per ClinicalTrials.gov, last updated 2010-07-07.

Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Constipation

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Keywords

  • Constipation (idiopathic)
03

In context

Constipation

1,040 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 867 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 79 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
60 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Small and large bowel transit time

    Time frame: 2 weeks after treatment

07

Study locations

3 of 3 sites recruiting
  • Caritas Medical Centre
    Hong Kong, China
    • Yat Wah Yeung, Dr · Sub investigator
    Recruiting
  • Princess Margaret Hospital
    Hong Kong, China
    • King Sun Chu, Dr · Sub investigator
    • Ka Man Ng, Dr · Sub investigator
    • Wing Hang Wong, Dr · Sub investigator
    • Hon Yeun, Dr · Sub investigator
    Recruiting
  • Yan Chai Hospital
    Hong Kong, China
    • Wai Keung Kwan, Dr · Sub investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2004 and a completion of Oct 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2007
First posted
Nov 26, 2007
Start
Nov 2004
CompletionEst.
Oct 2006
Last update
Jul 7, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00563615
Lead sponsor
Hospital Authority, Hong Kong
First posted
Nov 26, 2007
Start date
Nov 2004
Completion
Oct 2006 (estimated)
Last update
Jul 7, 2010

Study contacts

Ambrose CP Kwan, Dr
Contact
argylest@netvigator.com
(852) 2990 1111
Ambrose CP Kwan, Dr
principal investigator · Department of Medicine and Geriatrics, Unit A, Princess Margaret Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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