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Safety and Therapeutic Efficacy of Phosphate Enema (Kleen Enema) in Patients Undergoing Sigmoidoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Dow University of Health Sciences
Information provided by (Responsible Party):
Nabiqasim Industries (Pvt) Ltd

Brief Summary:
The Purpose of the study is to determine the efficacy of Kleen Enema® (Phosphate Enema) for bowel preparation in out-patients under going sigmoidoscopy procedure and to evaluate the safety behavior of Kleen Enema® in outpatients requiring sigmoidoscopy

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Phosphate Enema (Kleen® Enema) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male/Female; aged 18-60 years.
  2. Out-patients admitted for day care sigmoidoscopy requiring left sided bowel preparation
  3. Able to understand the informed consent, answer the questions either independently or with someone helps

Exclusion Criteria:

  1. In-patients undergoing sigmoidoscopy or as emergency procedures.
  2. Immunosuppressed patients.
  3. Patients with electrolyte imbalance or disturbance, Hyperphosphatemia, Hypocalcemia, Hypokalemia, Hypernatremia, Metabolic acidosis.
  4. Patients having nausea, vomiting, diarrhea at the time of investigational drug administration.
  5. Patients administering the medications known to affect renal perfusion, function, or hydration(Renal failure or acute kidney injury)
  6. Patients taking diuretics or other medications within two days prior to the procedure which may alter electrolytes
  7. Patients with known hypersensitivity to any ingredient of the study drug/phosphate.
  8. Patients requiring colostomy.
  9. Conditions causing decreased gastric motility, e.g.,Suspected intestinal obstruction,Paralytic ileus Anorectal stenosis, Imperforate anus, Congenital or acquired megacolon
  10. Undiagnosed gastrointestinal pathology, e.g. Symptoms of appendicitis, intestinal perforation or active inflammatory bowel disease, Undiagnosed rectal bleeding, Dehydration and generally in all cases where absorption capacity is increased or elimination capacity is decreased
  11. Patients with any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any Cardiovascular disease,History of asthma, glaucoma, or raised intraocular pressure.

Information from the National Library of Medicine

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


Contacts
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Contact: Tasneem Ahmad, B.Pharm,Ph.D +92 314 2120868 dr.tasneem@phaps.com
Contact: Ghousia Saba, B.Pharm. 92 21 36352328 Ghousia@phaps.com

Locations
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Pakistan
National Institute of Liver and GI diseases, DUHS Recruiting
Karachi, Sindh, Pakistan, 74200
Contact: Zahid Azam, FCPS,MBBS    +92-21-99215754-7    zahid.azam@duhs.edu.pk   
Contact: Hafeezullah Shaikh, FCPS, MBBS    +92-21-99215754-7    hafeezullah.shaikh@duhs.edu.pk   
Sponsors and Collaborators
Nabiqasim Industries (Pvt) Ltd
Dow University of Health Sciences
Investigators
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Principal Investigator: Hafeezullah Shaikh, FCPS, MBBS Dow University of Health Sciences
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Responsible Party: Nabiqasim Industries (Pvt) Ltd
ClinicalTrials.gov Identifier: NCT02386904    
Other Study ID Numbers: • KLEE-EFF-002-01
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases