clinical trial to evaluate the effectiveness of two administration schedules of CitraFleet to cleanse the colo

• Conditions: Cleansing of colon; MedDRA version: 16.1Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2013-001620-20-DE
• Lead Sponsor: aboratorios Casen-Fleet S.L.U.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-21
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Age: 18 years and older
2. men or non-pregnant women.
3. Subjects undergoing elective colonoscopy
4. Subjects who, in the opinion of the Investigator, are able and willing to follow their assigned low-residue diet and hydration regimen
5. Subjects who, in the opinion of the Investigator, are able and willing to comply with study requirements, with special emphasis on dosing instructions and diary completion.
6. Subjects who have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
7. Subjects who have hand-signed and dated their informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Congestive heart failure or decompensated heart insufficiency
2. Gastrointestinal conditions contraindicating the administration of CitraFleet: nausea and vomiting, gastric retention, gastro-intestinal ulceration, ileus, toxic colitis, toxic megacolon, gastro-intestinal obstruction or perforation, active inflammatory bowel disease
3. Ascites
4. Acute surgical abdominal conditions such as acute appendicitis
5. Severe dehydration
6. Hypermagnesaemia
7. Rhabdomyolysis
8. Hypersensitivity to any of the ingredients of the IP
9. Ingestion of an investigational product within 1 month prior to screening
10. Severe chronic kidney disease (ie, stage >3 chronic kidney disease [CKD])
11. Have, in the opinion of the investigator, any condition that may make them unsuitable for inclusion in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified