Condition category
Digestive System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Bond

ORCID ID

Contact details

Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 6777
john.bond@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 98/32/99

Study information

Scientific title

Acronym

STOOL

Study hypothesis

1. To investigate the clinical and cost effectiveness of bulk forming, stimulant and osmotic laxatives prescribed by primary care to ambulant older people living at home.
2. To investigate the clinical and cost effectiveness of prescribing an additional second type of laxative agent in the treatment of patients whose constipation is not resolved by a single agent.
3. To describe the adherence by patients to treatment protocols.

Ethics approval

Not provided at time of registration.

Study design

Pragmatic factorial randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Constipation

Intervention

Different forms of stepped pharmacological treatment of constipation with economic evaluation. An add-on qualitative study of the meaning and experience of constipation to older people and the views of general practitioners.

Added as of 25/08/2009: the trial was closed after recruiting 19 participants due to problem with recruitment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary clinical outcome is the reported number of bowel movements per week at the end of each step (6 and 10 weeks after randomisation) and at six months follow-up.

Secondary outcome measures

Secondary clinical outcomes include the presence/absence of the other Rome criteria for constipation; adverse effects of treatment (although some of these may also be symptoms of constipation); and relapse rates. In addition to the measurement of these clinical outcomes, patient satisfaction and the impact of the treatment on costs and quality of life will be assessed

Overall trial start date

01/10/2002

Overall trial end date

30/04/2006

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

People aged 55 or over with chronic constipation living in private households.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

19

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/10/2002

Recruitment end date

30/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Health Services Research
Newcastle upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18462572

Publication citations

  1. Results

    Mihaylov S, Stark C, McColl E, Steen N, Vanoli A, Rubin G, Curless R, Barton R, Bond J, Stepped treatment of older adults on laxatives. The STOOL trial., Health Technol Assess, 2008, 12, 13, iii-iv, ix-139.

Additional files

Editorial Notes