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

NCT ID: NCT01715272

Last Updated: 2013-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-01-31

Brief Summary

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

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fleet enema

This group will receive Fleet enema as their treatment

Group Type: ACTIVE_COMPARATOR

Fleet enema

Intervention Type: DRUG

TF037

This group will receive TF037 as their treatment

Group Type: EXPERIMENTAL

TF037

Intervention Type: DEVICE

Interventions

TF037

Intervention Type: DEVICE

Fleet enema

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronnie Beboso, MD

Role: PRINCIPAL_INVESTIGATOR

BioKinetic Europe Ltd.

Locations

BioKinetic Europe Ltd

Belfast, Northern Ireland, United Kingdom

BioKinetic Europe Ltd

Belfast, , United Kingdom

Countries

United Kingdom

Other Identifiers

NER1008-01/2012 (DBC)

Identifier Type: -

Identifier Source: org_study_id