A Double-blind randomised controlled trial to compare buscopan versus placebo as an adjunct to colonoscopy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002966-39-GB

Enrollment

300

Registered

2007-01-08

Start date

2006-12-22

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pathology of the large bowel as detected by colonoscopy

Interventions

Trade Name: Buscopan Product Name: Buscopan Product Code: N/A Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the plac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: all patients due to undergo colonoscopy at the Northern General Hospital in Sheffield will be invited to take part in this study. This will include patients requesting Midazolam (intravenous sedation) or Entonox (inhaled analgesia) during their colonoscopy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: allergy to buscopan; previous bowel resection; glaucoma; obstructive uropathy; autonomic dysfunction; myasthenia gravis; concurrent anticholinergic medication;l inability to consent or understand or read English.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): the primary endpoints are: 1) spasm - does buscopan decrease spasms of the bowel? 2) mucosal visualisation - does buscopan allow for greater visualisation of pathologies of the large bowel? ;Main Objective: the principle research questions are: 1) does the routine use of buscopan decrease bowel spasm? 2) does the routine use of buscopan improve mucosal visualisation and therefore, the detection of pathology (i.e. polyps, cancers, flat adenomas, vascular lesion). ;Secondary Objective: the secondary research questions are: 1) does the routine use of buscopan ease and speed the insertion and withdrawel of the endoscope? 2) does the routine use of buscopan during colonoscopy influence patients discomfort during the procedure 3) does the routine ise of buscopan during colonoscopy cause adverse effects?	—

Measure

Time frame

Primary end point(s): the primary endpoints are: 1) spasm - does buscopan decrease spasms of the bowel? 2) mucosal visualisation - does buscopan allow for greater visualisation of pathologies of the large bowel? ;Main Objective: the principle research questions are: 1) does the routine use of buscopan decrease bowel spasm? 2) does the routine use of buscopan improve mucosal visualisation and therefore, the detection of pathology (i.e. polyps, cancers, flat adenomas, vascular lesion). ;Secondary Objective: the secondary research questions are: 1) does the routine use of buscopan ease and speed the insertion and withdrawel of the endoscope? 2) does the routine use of buscopan during colonoscopy influence patients discomfort during the procedure 3) does the routine ise of buscopan during colonoscopy cause adverse effects?

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026