Efficacy and Safety Study of Sodium Phosphate Tablets vs PEG for Bowel Cleansing

Colon Cleansing Clinical Trial

Official title:

A Randomized Assessor-blinded Multicenter International Study Investigating Efficacy Patients Acceptance Safety and Tolerability of Sodium Phosphate Tablets Compared to Split Dose Polyethylene Glycol for Colon Cleansing Prior to Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840553
• Other study ID #: ICOL121
• Secondary ID: 2012-005115-13
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2013
• Last updated: March 21, 2014
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2013
• Source: Laboratoires Mayoly Spindler
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women aged from 18 to 75 years (included).

• Scheduled for a colonoscopy as an outpatient.

• Normal renal function

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cleansing

Intervention

Drug:
• oral sodium phosphate tablets

• polyethylene glycol

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Hopital Edouard Herriot	Lyon
France	Groupe Hospitalier Intercommunal Le Raincy-Montfermeil	Montfermeil
France	CHU Hotel Dieu	Nantes
France	Hopital l'Archet	Nice
France	CHU Cochin	Paris
France	Clinique Saint-Jean Languedoc	Toulouse
Germany	Sana Klinikum Lichtenberg	Berlin
Germany	Kreisklinik Biberach	Biberach
Germany	Klinikum Heidenheim	Heidenheim
Germany	Medizinische Klinik und Poliklinik II Munchen	Munchen
Spain	Complejo Hospitalario de A Coruna	A Coruna
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de Fuenlabrada	Fuenlabrada
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitarion Gregorio Maranon	Madrid
Spain	Clinica Universidad de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Mayoly Spindler

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall quality of bowel cleansing		day 1	No