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Trial record 10 of 413 for:    sodium phosphate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01715272
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Colonoscopy Device: TF037 Drug: Fleet enema Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Stool output as measured by stool weight [ Time Frame: up to 1 hour following enema administration ]
    To compare the stool output (as measured as stool weight) during the 1 hour period following enema administration for TF037 and Fleet enema

  2. Safety and tolerability as assessed by use of a Visual Analogue scale (VAS) [ Time Frame: 5 and 30 minutes following enema administration ]
    To assess the safety (including effects on water homeostasis) and tolerability of this medical device in its intended purpose

  3. Stool output over time [ Time Frame: 1 hour following enema administration ]
    To assess kinetics of bowel movements in relation to stool output over time

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01715272

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

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Responsible Party: Norgine Identifier: NCT01715272     History of Changes
Other Study ID Numbers: NER1008-01/2012 (DBC)
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013