Colonic AdenomasPhase 4NCT01609855
Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?
A Phase 4 study testing Hyoscine Butyl Bromide 20mg/2 ml i.v. and Saline 2 ml i.v. in people with Colonic Adenomas, run by Valduce Hospital at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Adenomas
- What is being tested?
- Hyoscine Butyl Bromide 20mg/2 ml i.v. and Saline 2 ml i.v.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2012to Jun 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients referred for colonoscopy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Valduce
Como, 20122
Gianni Imperiali, MD
Vittorio Terruzzi, MD
- Recruiting
Ospedale Valduce
Como, 20122
Spinzi Giancarlo, MD, 0039031324141, gispinz@tin.it
About this study
Official title: Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study
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.
Read the detailed description
Outpatients referred for colonoscopy were screened for possible enrollment. Exclusion criteria included: glaucoma, benign prostatic hyperplasia or urinary obstruction, previous intestinal resection, ongoing therapy with tricyclic antidepressants, chronic renal failure and history of IBD. Eligible patients were randomized to receive either 20 mg/2ml of HBB i.v. or 2ml of saline i.v.; both the endoscopist and the patient were blind to the administered drug. The endoscopist was asked to inspect the right, transverse and left colon for at least 2 min for each segment. The number, size and location of polyps were recorded as well as the occurrence episodes of tachycardia (defined as bpm>140). As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100).
- Conditions
- Colonic Adenomas
- Being tested
- Hyoscine Butyl Bromide 20mg/2 ml i.v., Saline 2 ml i.v.
- Keywords
- Adenoma Detection Rate, Anti-spasmotic drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine Butyl Bromide 20mg/2 ml i.v.Drug
Also called Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.
Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation
Saline 2 ml i.v.Drug
Also called Saline
Administration of Saline 2 ml at time of caecal intubation
| Study group | Role | What they receive |
|---|---|---|
| HBB- Hioscine Butyl Bromide | Experimental | Not described Receives: Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v. |
| Placebo arm | Placebo comparator | Not described Receives: Drug: Saline 2 ml i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)
Measured: 5 months
Secondary outcomes (1)
Tolerability of HBB
As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100).
Measured: this outcome will be evaluated at the end of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic AdenomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Rondonotti, Valduce Hospital
- Investigators
- Spinzi Giancarlo, MD, Study director, Gastroenterology Unit, Ospedale Valduce, Como, Italy.Franco Radaelli, MD, Study chair, Gastroenterology Unit, Ospedale Valduce, Como. Italy.Emanuele Rondonotti, MD, Principal investigator, Gastroenterology Unit, Ospedale Valduvce, Como. Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609855
- Sponsor's protocol ID
- HBB-1
- Status last verified
- May 2012
- First submitted
- 7 May 2012
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01609855
- Acronym / sponsor ID
- HBB-1
- Conditions
- Colonic Adenomas
- Keywords
- Adenoma Detection Rate, Anti-spasmotic drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Outpatients referred for colonoscopy were screened for possible enrollment. Exclusion criteria included: glaucoma, benign prostatic hyperplasia or urinary obstruction, previous intestinal resection, ongoing therapy with tricyclic antidepressants, chronic renal failure and history of IBD. Eligible patients were randomized to receive either 20 mg/2ml of HBB i.v. or 2ml of saline i.v.; both the endoscopist and the patient were blind to the administered drug. The endoscopist was asked to inspect the right, transverse and left colon for at least 2 min for each segment. The number, size and location of polyps were recorded as well as the occurrence episodes of tachycardia (defined as bpm>140). As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBB- Hioscine Butyl Bromide | Experimental | Drug: Hyoscine Butyl Bromide 20mg/2 ml i.v. |
| Placebo arm | Placebo comparator | Drug: Saline 2 ml i.v. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients referred for colonoscopy
Key exclusion criteria (8 listed)
- glaucoma
- benign prostatic hyperplasia or urinary obstruction
- previous intestinal resection,
- ongoing therapy with tricyclic antidepressants
- chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyoscine Butyl Bromide 20mg/2 ml i.v.Also: Buscopan: Hyoscine Butyl Bromide 20mg/2 ml i.v.Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation | Drug | HBB- Hioscine Butyl Bromide |
| Saline 2 ml i.v.Also: SalineAdministration of Saline 2 ml at time of caecal intubation | Drug | Placebo arm |
Primary outcome
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)
Time frame: 5 months
1 secondary outcome
Tolerability of HBB
Time frame: this outcome will be evaluated at the end of colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spinzi Giancarlo, MD study director
Gastroenterology Unit, Ospedale Valduce, Como, Italy.
Franco Radaelli, MD study chair
Gastroenterology Unit, Ospedale Valduce, Como. Italy.
Emanuele Rondonotti, MD principal investigator
Gastroenterology Unit, Ospedale Valduvce, Como. Italy.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyoscine Butyl Bromide 20mg/2 ml i.v. and Saline 2 ml i.v. in people with Colonic Adenomas, run by Valduce Hospital at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Rondonotti, MD (0039031324145, ema.rondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.