Gastrointestinal ComplicationPhase 4NCT02040285
Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)
A Phase 4 study testing Bisacodyl & PEG-CS and Iopamidol in people with Gastrointestinal Complication, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient tolerability and acceptance. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastrointestinal Complication
- What is being tested?
- Bisacodyl & PEG-CS and Iopamidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Jul 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-patients undergoing a CTC
- Patient written informed consent
Who cannot join
- Pregnant or lactating women or at a risk of becoming pregnant
- Known or suspected gastrointestinal obstruction or perforation, toxic megacolon, ileo, major colonic surgery
- History of anaphylaxis to Iopamidol or allergic reactions to drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC). Comparison vs Laxative Free CTC.
The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient tolerability and acceptance.
Read the detailed description
Computed Tomography Colonography (CTC) is a valid alternative to colonoscopy in the detection of cancer, polyps and other colon lesions.
High volume cathartic preparations, low volume cathartic solutions with oral tagging agent and tagging agent only are the procedures available for CTC.
High volume preparations are a considerable burden for patients. Low volume cathartic solutions are more accepted by the patients, reduce the amount of tagging agent and the waiting time to the exam. Tagging agent only preparations represent a risk if they are taken without medical supervision.
- Conditions
- Gastrointestinal Complication
- Being tested
- Bisacodyl & PEG-CS, Iopamidol
- Keywords
- CT colonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisacodyl & PEG-CSDrug
Also called Lovoldyl (Bisacodyl), Lovolesse (PEG-CS), Gastromiro (Iopamidol), Plasil (Metoclopramide mono chlorohydrate monohydrate)
the day before the CTC:
- low fiber diet
- at 15.00: 2 tablets of bisacodyl (5 mg)
- at 17.00: 1 litre of PEG-CS
- liquid diet the day of the exam:
- at home: 2 tablets of bisacodyl (5 mg)
- at the Hospital (3 hours after tablets intake): 90 ml of Iopamidol in 500 ml of water
- at the Hospital (5 minutes after Iopamidol intake): 10 mg of Metoclopramide mono chlorohydrate monohydrate im
IopamidolDrug
Also called Gastromiro (Iopamidol)
the day before CTC:
- low fiber diet
- at 15.00: 90 ml of Iopamidol in 250 ml of water
- at 17.00: 90 ml of Iopamidol in 250 ml of water
- at 20.00: start liquid diet
| Study group | Role | What they receive |
|---|---|---|
| Free laxative CTC | Active comparator | Not described Receives: Drug: Iopamidol |
| Low-dose laxative bowel preparation for CTC | Experimental | Not described Receives: Drug: Bisacodyl & PEG-CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Tagging. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 0= greater than 75% of residuals to 3= minor than 25% of residuals).
Measured: 20 min
Secondary outcomes (5)
Efficacy
Residual fluid evaluation. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 1= minor than 25% of the ap axis to 4= greater than 75% of the ap axis).
Measured: 20 minutes
Efficacy
Bowel distension. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 0= greater than 75% of the maximal distension to 3= minor than 25% of the maximal distension)
Measured: 20 min
Safety
Recording of all Adverse Events (AEs) occurring during the 2 days of treatment
Measured: 2 days (the day before and the day of CTC)
Safety
Tolerability. Recording of gastrointestinal (GI) symptoms occurring during the 2 days of treatment. Intensity of GI symptoms will be evaluated by a Visual Analgic Scale (VAS) ranging from 0=no symptoms to 10=severe, as much as possible.
Measured: 2 days (the day before and the day of the exam)
Acceptability
Evaluation of the patient discomfort related to bowel preparation. A 4 point scale is used: 1=none; 2=mild distress; 3=moderate distress; 4=severe distress.
Measured: 2 days (the day before and the day of the exam)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Laghi, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040285
- Sponsor's protocol ID
- CTC-Prep 1
- Status last verified
- Jan 2014
- First submitted
- 13 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC). Comparison vs Laxative Free CTC.
- ClinicalTrials.gov ID
- NCT02040285
- Acronym / sponsor ID
- CTC-Prep 1
- Conditions
- Gastrointestinal Complication
- Keywords
- CT colonography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Jan 2014 (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 aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient tolerability and acceptance.
Detailed description
Computed Tomography Colonography (CTC) is a valid alternative to colonoscopy in the detection of cancer, polyps and other colon lesions.
High volume cathartic preparations, low volume cathartic solutions with oral tagging agent and tagging agent only are the procedures available for CTC.
High volume preparations are a considerable burden for patients. Low volume cathartic solutions are more accepted by the patients, reduce the amount of tagging agent and the waiting time to the exam. Tagging agent only preparations represent a risk if they are taken without medical supervision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free laxative CTC | Active comparator | Drug: Iopamidol |
| Low-dose laxative bowel preparation for CTC | Experimental | Drug: Bisacodyl & PEG-CS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Out-patients undergoing a CTC
- Patient written informed consent
Key exclusion criteria (3 listed)
- Pregnant or lactating women or at a risk of becoming pregnant
- Known or suspected gastrointestinal obstruction or perforation, toxic megacolon, ileo, major colonic surgery
- History of anaphylaxis to Iopamidol or allergic reactions to drugs
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 |
|---|---|---|
| Bisacodyl & PEG-CSAlso: Lovoldyl (Bisacodyl), Lovolesse (PEG-CS), Gastromiro (Iopamidol), Plasil (Metoclopramide mono chlorohydrate monohydrate)the day before the CTC: * low fiber diet * at 15.00: 2 tablets of bisacodyl (5 mg) * at 17.00: 1 litre of PEG-CS * liquid diet the day of the exam: * at home: 2 tablets of bisacodyl (5 mg) * at the Hospital (3 hours after tablets intake): 90 ml of Iopamidol in 500 ml of water * at the Hospital (5 minutes after Iopamidol intake): 10 mg of Metoclopramide mono chlorohydrate monohydrate im | Drug | Low-dose laxative bowel preparation for CTC |
| IopamidolAlso: Gastromiro (Iopamidol)the day before CTC: * low fiber diet * at 15.00: 90 ml of Iopamidol in 250 ml of water * at 17.00: 90 ml of Iopamidol in 250 ml of water * at 20.00: start liquid diet | Drug | Free laxative CTC |
Primary outcome
Efficacy
Time frame: 20 min
Tagging. In prone and supine position, each colon segment (caecum, ascending, transverse, descending, sigma and rectum) will be graded by using a 4 point scale (from 0= greater than 75% of residuals to 3= minor than 25% of residuals).
5 secondary outcomes
Efficacy
Time frame: 20 minutes
Efficacy
Time frame: 20 min
Safety
Time frame: 2 days (the day before and the day of CTC)
Safety
Time frame: 2 days (the day before and the day of the exam)
Acceptability
Time frame: 2 days (the day before and the day of the exam)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisacodyl & PEG-CS and Iopamidol in people with Gastrointestinal Complication, run by Azienda Policlinico Umberto I at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 20 min). 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 20 Jan 2014.