NCT01609855

Brief Summary

The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at time of caecal intubation, increases the adenoma detection rate.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

May 7, 2012

Last Update Submit

May 31, 2012

Conditions

Colonic Adenomas

Keywords

Adenoma Detection RateAnti-spasmotic drug

Outcome Measures

Primary Outcomes (1)

  • Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)

    5 months

Secondary Outcomes (1)

  • Tolerability of HBB

    this outcome will be evaluated at the end of colonoscopy

Study Arms (2)

HBB- Hioscine Butyl Bromide

EXPERIMENTAL
Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v.

Placebo arm

PLACEBO COMPARATOR
Drug: Saline 2 ml i.v.

Interventions

Hyoscine Butyl Bromide 20mg/2 ml i.v.DRUG

Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation

Also known as: Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.
HBB- Hioscine Butyl Bromide
Saline 2 ml i.v.DRUG

Administration of Saline 2 ml at time of caecal intubation

Also known as: Saline
Placebo arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatients referred for colonoscopy

You may not qualify if:

  • glaucoma
  • benign prostatic hyperplasia or urinary obstruction
  • previous intestinal resection,
  • ongoing therapy with tricyclic antidepressants
  • chronic renal failure
  • history of IBD
  • participation other studies
  • unsedated colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale Valduce

Como, 20122, Italy

RECRUITING

Ospedale Valduce

Como, 20122, Italy

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Spinzi Giancarlo, MD

    Gastroenterology Unit, Ospedale Valduce, Como, Italy.

    STUDY DIRECTOR

  • Franco Radaelli, MD

    Gastroenterology Unit, Ospedale Valduce, Como. Italy.

    STUDY CHAIR

  • Emanuele Rondonotti, MD

    Gastroenterology Unit, Ospedale Valduvce, Como. Italy.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuele Rondonotti, MD

CONTACT

0039031324145ema.rondo@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 7, 2012

First Posted

June 1, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations

IT(2)