Safety and Therapeutic Efficacy of Phosphate Enema (Kleen Enema) in Patients Undergoing Sigmoidoscopy
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|ClinicalTrials.gov Identifier: NCT02386904|
Recruitment Status : Unknown
Verified March 2015 by Nabiqasim Industries (Pvt) Ltd.
Recruitment status was: Recruiting
First Posted : March 12, 2015
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Phosphate Enema (Kleen® Enema)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Interventional, Single Arm Study in Outpatients Undergoing Sigmoidoscopy for Evaluation of Efficacy and Safety of Kleen Enema 120ml (Phosphate Enema)|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||August 2015|
Experimental: Phosphate Enema
Phosphate Enema consisting on Monobasic Sodium Phosphate (USP) 19.2 gm /120 ml and Dibasic Sodium Phosphate (USP) 7.2 gm/120 ml Dosage Form: Enema Frequency: One time; 30 minutes before Sigmoidoscopy
Drug: Phosphate Enema (Kleen® Enema)
120ml (single bottle) administered via rectal route before 30min of sigmoidoscopy .
Other Name: Brand name is Kleen® Enema
- Excellent Preparation for Sigmoidoscopy (efficacy) [ Time Frame: 30 minutes after administration of the Enema ]i. Small amounts of faecal material in scattered locations removable by suctioning and not preventing satisfactory visualisation of bowel mucosa; ii. Excellent preparation, no faecal material.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386904
|Contact: Tasneem Ahmad, B.Pharm,Ph.D||+92 314 email@example.com|
|Contact: Ghousia Saba, B.Pharm.||92 21 36352328||Ghousia@phaps.com|
|National Institute of Liver and GI diseases, DUHS||Recruiting|
|Karachi, Sindh, Pakistan, 74200|
|Contact: Zahid Azam, FCPS,MBBS +92-21-99215754-7 firstname.lastname@example.org|
|Contact: Hafeezullah Shaikh, FCPS, MBBS +92-21-99215754-7 email@example.com|
|Principal Investigator:||Hafeezullah Shaikh, FCPS, MBBS||Dow University of Health Sciences|