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

• Status: Unknown status
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nabiqasim Industries (Pvt) Ltd
• Collaborator: Dow University of Health Sciences

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.