Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

December 2, 2014

Primary Completion Date

January 26, 2016

Study Completion Date

January 26, 2016

Conditions
Diabetes MellitusColonic Diseases
Interventions
DRUG

PEG-ascorbate 2L

"Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.~Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 2 sachets (labelled A and B) of the investigational product and take their contents diluted in 1 liter of water. Two other sachets, also labelled A and B, will be taken diluted in 1 liter of water 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken."

DRUG

PEG 4L

"Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.~Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken."

Trial Locations (2)

08916

Hospital Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

All Listed Sponsors
collaborator

Germans Trias i Pujol Hospital

OTHER

lead

Parc de Salut Mar

OTHER

NCT02297399 - Improvement of Tolerance of Bowel Cleansing Before Colonoscopy in Diabetic Patients | Biotech Hunter | Biotech Hunter