Overview

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.