NCT02386904

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

March 7, 2015

Last Update Submit

March 16, 2015

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Excellent Preparation for Sigmoidoscopy (efficacy)

    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.

    30 minutes after administration of the Enema

Study Arms (1)

Phosphate Enema

EXPERIMENTAL

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)

Interventions

Phosphate Enema (Kleen® Enema)DRUG

120ml (single bottle) administered via rectal route before 30min of sigmoidoscopy .

Also known as: Brand name is Kleen® Enema
Phosphate Enema

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • In-patients undergoing sigmoidoscopy or as emergency procedures.
  • Immunosuppressed patients.
  • Patients with electrolyte imbalance or disturbance, Hyperphosphatemia, Hypocalcemia, Hypokalemia, Hypernatremia, Metabolic acidosis.
  • Patients having nausea, vomiting, diarrhea at the time of investigational drug administration.
  • Patients administering the medications known to affect renal perfusion, function, or hydration(Renal failure or acute kidney injury)
  • Patients taking diuretics or other medications within two days prior to the procedure which may alter electrolytes
  • Patients with known hypersensitivity to any ingredient of the study drug/phosphate.
  • Patients requiring colostomy.
  • Conditions causing decreased gastric motility, e.g.,Suspected intestinal obstruction,Paralytic ileus Anorectal stenosis, Imperforate anus, Congenital or acquired megacolon
  • 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
  • Patients with any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any Cardiovascular disease,History of asthma, glaucoma, or raised intraocular pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Liver and GI diseases, DUHS

Karachi, Sindh, 74200, Pakistan

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Hafeezullah Shaikh, FCPS, MBBS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasneem Ahmad, B.Pharm,Ph.D

CONTACT

+92 314 2120868dr.tasneem@phaps.com

Ghousia Saba, B.Pharm.

CONTACT

92 21 36352328Ghousia@phaps.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2015

First Posted

March 12, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

PA(1)