NCT02248337

Brief Summary

Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

September 20, 2014

Last Update Submit

September 23, 2014

Conditions

Inflammatory Bowel Disease

Keywords

Colon preparation; Colonoscopy; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Quality of colon cleansing assesse with Ottawa bowel preparation score

    During endoscopy within 24 hours after preparation

Secondary Outcomes (3)

  • Compliance

    during product assumption

  • Tollerability

    during product assumption

  • safety

    From drug intake to the end of colonoscopy

Study Arms (2)

4 Liter PEG

ACTIVE COMPARATOR

Colon preparation for colonoscopy: PEG 4 Liter before endoscopy

Drug: Colon preparation for colonoscopy

2 Liter PEG plus bisacodil

EXPERIMENTAL

Colon preparation for colonoscopy: PEG 2 L before endoscopy

Drug: Colon preparation for colonoscopy

Interventions

Colon preparation for colonoscopyDRUG

Colon cleansing prior to perform colonoscopy

Also known as: Colon cleansing
2 Liter PEG plus bisacodil4 Liter PEG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult outpatiets with IBD colitis undergoing colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luigi Sacco University Hospital

Milan, I-20157, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26164666DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • gianpiero manes, MD

    AO G. Salvini Garbagnate Milanes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 20, 2014

First Posted

September 25, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

IT(1)