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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norgine
ClinicalTrials.gov Identifier:
NCT01715272
First received: October 24, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Colonoscopy
Device: TF037
Drug: Fleet enema
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale [ Time Frame: Between 1 to 3 hours following enema administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stool output as measured by stool weight [ Time Frame: up to 1 hour following enema administration ] [ Designated as safety issue: No ]
    To compare the stool output (as measured as stool weight) during the 1 hour period following enema administration for TF037 and Fleet enema

  • Safety and tolerability as assessed by use of a Visual Analogue scale (VAS) [ Time Frame: 5 and 30 minutes following enema administration ] [ Designated as safety issue: No ]
    To assess the safety (including effects on water homeostasis) and tolerability of this medical device in its intended purpose

  • Stool output over time [ Time Frame: 1 hour following enema administration ] [ Designated as safety issue: No ]
    To assess kinetics of bowel movements in relation to stool output over time


Enrollment: 60
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715272

Locations
United Kingdom
BioKinetic Europe Ltd
Belfast, Northern Ireland, United Kingdom, BT2 7BA
BioKinetic Europe Ltd
Belfast, United Kingdom
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Ronnie Beboso, MD BioKinetic Europe Ltd.
  More Information

No publications provided

Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT01715272     History of Changes
Other Study ID Numbers: NER1008-01/2012 (DBC)
Study First Received: October 24, 2012
Last Updated: February 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 23, 2014