NCT01840553

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of sodium phosphate tablets compared to split dose of 4 liters of PEG used in adults for bowel cleansing prior to colonoscopy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
461

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2013

Shorter than P25 for phase_3

Geographic Reach
3 countries

19 active sites

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

First Submitted

Initial submission to the registry

April 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 24, 2014

Status Verified

November 1, 2013

Enrollment Period

10 months

First QC Date

April 23, 2013

Last Update Submit

March 21, 2014

Conditions

Colon Cleansing

Outcome Measures

Primary Outcomes (1)

  • overall quality of bowel cleansing

    day 1

Study Arms (2)

polyethylene glycol

ACTIVE COMPARATOR

4 Liters of PEG administered split in 2 doses

Drug: polyethylene glycol

oral sodium phosphate tablets

EXPERIMENTAL

oral Sodium Phosphate tablets administered as 32 tablets (20+12) with 2 Liters of liquid

Drug: oral sodium phosphate tablets

Interventions

oral sodium phosphate tabletsDRUG
oral sodium phosphate tablets
polyethylene glycolDRUG
polyethylene glycol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged from 18 to 75 years (included).
  • Scheduled for a colonoscopy as an outpatient.
  • Normal renal function

You may not qualify if:

  • Having a disease or condition as follows:
  • repeated episodes of nausea and vomiting
  • abdominal pain due to severe infection or requiring surgery
  • clinically significant abnormal electrolytes values
  • congestive heart failure, unstable angina pectoris or recent myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within previous 3 months
  • known/suspected bowel obstruction, megacolon, ileus or intestinal perforation, or gastroparesis,
  • inflammatory bowel disease,
  • history of gastric stapling or bypass procedure or gastric retention
  • Sodium phosphate preparation taken within the past three weeks prior to colonoscopy.
  • Known allergy to any of the active ingredients or excipients of the study drugs.
  • History of phenylketonuria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Hôpital Avicenne

Bobigny, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Location

Hopital Edouard Herriot

Lyon, France

Location

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, France

Location

CHU Hotel Dieu

Nantes, France

Location

Hopital l'Archet

Nice, France

Location

CHU Cochin

Paris, France

Location

Clinique Saint-Jean Languedoc

Toulouse, France

Location

Sana Klinikum Lichtenberg

Berlin, Germany

Location

Kreisklinik Biberach

Biberach, Germany

Location

Klinikum Heidenheim

Heidenheim, Germany

Location

Medizinische Klinik und Poliklinik II Munchen

München, Germany

Location

Complejo Hospitalario de A Coruna

A Coruña, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital de Fuenlabrada

Fuenlabrada, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitarion Gregorio Maranon

Madrid, Spain

Location

Clinica Universidad de Navarra

Pamplona, Spain

Location

Related Publications (1)

  • Chaussade S, Schmocker C, Toulemonde P, Munoz-Navas M, O'Mahony V, Henri F. Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial. Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18.

    PMID: 27864718DERIVED

MeSH Terms

Interventions

sodium phosphatePolyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 25, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 24, 2014

Record last verified: 2013-11

Locations

FR(8)ES(7)DE(4)