Inflammatory Bowel DiseasePhase 4NCT02248337
Low Volume Colon Preparation for IBD
A Phase 4 study testing Colon preparation for colonoscopy in people with Inflammatory Bowel Disease, run by Luigi Sacco University Hospital at 1 site in Italy.
Trial summary
Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Colon preparation for colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Mar 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Adult outpatiets with IBD colitis undergoing colonoscopy
Who cannot join
- Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency
- Pregnant or breastfeeding women were also excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil
Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.
Read the detailed description
Low-volume preparations are gaining attention for higher acceptability. This study compares efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution in patients with inflammatory bowel disease-related colitis.
This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient acceptance, satisfaction, and related symptoms will be also recorded. The study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Colon preparation for colonoscopy
- Keywords
- Colon preparation; Colonoscopy; Inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon preparation for colonoscopyDrug
Also called Colon cleansing
Colon cleansing prior to perform colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 4 Liter PEG | Active comparator | Colon preparation for colonoscopy: PEG 4 Liter before endoscopy Receives: Drug: Colon preparation for colonoscopy |
| 2 Liter PEG plus bisacodil | Experimental | Colon preparation for colonoscopy: PEG 2 L before endoscopy Receives: Drug: Colon preparation for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Quality of colon cleansing assesse with Ottawa bowel preparation score
Measured: During endoscopy within 24 hours after preparation
Secondary outcomes (3)
Compliance
Intake of at least 75% of the product volume
Measured: during product assumption
Tollerability
Occurrence of discomfort during drug intake
Measured: during product assumption
safety
Occurrence of side effects
Measured: From drug intake to 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 posted25 Sep 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianpiero Manes, Luigi Sacco University Hospital
- Investigators
- gianpiero manes, MD, Study chair, AO G. Salvini Garbagnate Milanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248337
- Sponsor's protocol ID
- LOVOL-IBD
- Status last verified
- Sep 2014
- First submitted
- 20 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Manes G, Fontana P, de Nucci G, Radaelli F, Hassan C, Ardizzone S. Colon Cleansing for Colonoscopy in Patients with Ulcerative Colitis: Efficacy and Acceptability of a 2-L PEG Plus Bisacodyl Versus 4-L PEG. Inflamm Bowel Dis. 2015 Sep;21(9):2137-44. doi: 10.1097/MIB.0000000000000463.
PubMed 26164666
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil
- ClinicalTrials.gov ID
- NCT02248337
- Acronym / sponsor ID
- LOVOL-IBD
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Colon preparation; Colonoscopy; Inflammatory bowel disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Sep 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.
Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.
Detailed description
Low-volume preparations are gaining attention for higher acceptability. This study compares efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution in patients with inflammatory bowel disease-related colitis.
This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient acceptance, satisfaction, and related symptoms will be also recorded. The study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 Liter PEG | Active comparator | Drug: Colon preparation for colonoscopyColon preparation for colonoscopy: PEG 4 Liter before endoscopy |
| 2 Liter PEG plus bisacodil | Experimental | Drug: Colon preparation for colonoscopyColon preparation for colonoscopy: PEG 2 L before endoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Adult outpatiets with IBD colitis undergoing colonoscopy
Key exclusion criteria (2 listed)
- Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency
- Pregnant or breastfeeding women were also excluded
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 |
|---|---|---|
| Colon preparation for colonoscopyAlso: Colon cleansingColon cleansing prior to perform colonoscopy | Drug | 2 Liter PEG plus bisacodil, 4 Liter PEG |
Primary outcome
Efficacy
Time frame: During endoscopy within 24 hours after preparation
Quality of colon cleansing assesse with Ottawa bowel preparation score
3 secondary outcomes
Compliance
Time frame: during product assumption
Tollerability
Time frame: during product assumption
safety
Time frame: From drug intake to the end of colonoscopy
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 25 Sep 2014.
- Derived from this study: PubMed 26164666Manes G, Fontana P, de Nucci G, Radaelli F, Hassan C, Ardizzone S. Colon Cleansing for Colonoscopy in Patients with Ulcerative Colitis: Efficacy and Acceptability of a 2-L PEG Plus Bisacodyl Versus 4-L PEG. Inflamm Bowel Dis. 2015 Sep;21(9):2137-44. doi: 10.1097/MIB.0000000000000463.
Related trials for Inflammatory Bowel Disease
RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Primary Sclerosing Cholangitis
Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
Enrolling by invitationPhase 4
INSIGHT-IBD Pragmatic Study
Ulcerative Colitis (UC), Crohn Disease (CD)
Active, not recruitingPhase 4
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Pouchitis, Pouches, Ileoanal
RecruitingPhase 2
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
Ulcerative Colitis
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.
gianpiero manes, MD study chair
AO G. Salvini Garbagnate Milanes
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 Colon preparation for colonoscopy in people with Inflammatory Bowel Disease, run by Luigi Sacco University Hospital 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 1 inclusion and 2 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 25 Sep 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: During endoscopy within 24 hours after preparation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248337, which also lists 1 linked publication.
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 25 Sep 2014.