A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema

This study is designed to assess the difference between the performance of a new enema (TF037) against Fleet enema in distal bowel cleansing.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Fleet enema; Device: TF037

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • BioKinetic Europe Ltd
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT2 7BA
      • BioKinetic Europe Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female subjects [as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead electrocardiograms (ECGs) at screening] aged 18 to 60 years.
• Non-smokers from 3 months before enema administration and for the duration of the clinical investigation.
• Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2.
• Must voluntarily provide written informed consent to participate in the clinical investigation.
• Must understand the purposes and risks of the clinical investigation and agree to follow the restrictions and schedule of procedures as defined in the clinical investigation plan, and as confirmed during the informed consent process.
• Female subjects must be postmenopausal (for at least one year and confirmed by a serum follicle stimulating hormone (FSH) test at screening), surgically sterile, practising true sexual abstinence or must use an effective method of contraception.
• Female subjects of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at check-in of each period.
• The subject's primary care physician must confirm that there is nothing in their medical history that would preclude their enrolment into this clinical investigation.
• Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).

Exclusion Criteria:

• Subjects with a history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
• Subjects with a history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome, inflammatory bowel disease).
• Subjects with a clinically relevant history or presence of abnormal gastrointestinal motility.
• Subjects with a significant history of hereditary bowel disorders.
• Subjects with abnormal findings on the digital rectal examination performed at screening.
• Use of laxatives or motility altering drugs in the 3 months preceding enema administration.
• Use of any prescription or over-the-counter medication (including vitamins, herbal and mineral supplements) within 14 days prior to enema administration (or within 5 half lives if longer), with the exception of Investigator-approved hormonal contraceptives, hormone replacement therapy (HRT) and occasional paracetamol, aspirin or ibuprofen.
• Participation in a clinical drug study during the 30 days preceding enema administration in this clinical investigation.
• Donation of blood or blood products within 30 days prior to enema administration or during the clinical investigation, except as required for this clinical investigation
• Pregnant or lactating females.
• Any clinically significant illness within 28 days prior to enema administration.
• History or presence of any significant drug allergy, or a known allergy or contraindication to trisodium citrate, Fleet® enema or midazolam.
• Laboratory values at screening which are deemed to be clinically significant, unless agreed in advance by the Sponsor's Medical Representative and Principal Investigator.
• Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
• Current or history of drug or alcohol abuse within the 12 months prior to enema administration, or a positive drugs of abuse test at screening or check-in.
• Consumption of alcoholic beverages within 24 hours of check-inor during confinement.
• Subjects who, in the opinion of the Investigator, are unsuitable for participation in the clinical investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fleet enema; This group will receive Fleet enema as their treatment	Drug: Fleet enema
Experimental: TF037; This group will receive TF037 as their treatment	Device: TF037

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale	Between 1 to 3 hours following enema administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool output as measured by stool weight	To compare the stool output (as measured as stool weight) during the 1 hour period following enema administration for TF037 and Fleet enema	up to 1 hour following enema administration
Safety and tolerability as assessed by use of a Visual Analogue scale (VAS)	To assess the safety (including effects on water homeostasis) and tolerability of this medical device in its intended purpose	5 and 30 minutes following enema administration
Stool output over time	To assess kinetics of bowel movements in relation to stool output over time	1 hour following enema administration

Collaborators and Investigators

• Sponsor: Norgine
• Investigators: Principal Investigator: Ronnie Beboso, MD, BioKinetic Europe Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): February 28, 2013
• Last Update Submitted That Met QC Criteria: February 27, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: NER1008-01/2012 (DBC)