AzTrials
AzTrials

Bowel PreparationPhase 3NCT01073943

Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

A Phase 3 study testing PicoPrep, HalfLytely and bisacodyl in people with Bowel Preparation, run by Ferring Pharmaceuticals at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Bowel Preparation
What is being tested?
PicoPrep, HalfLytely and bisacodyl
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
603 participants
Where
11 sitesUnited States
Study dates
May 2010to Oct 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
  • Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period
  • Females of childbearing potential must undergo a pregnancy test at screening and again at randomization
  • Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy
  • Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions
  • Written informed consent obtained prior to study

Who cannot join

  • Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
  • Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
  • Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
  • Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome)
  • Ascites
  • Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
Show all 12Show fewer
  • Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
  • Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
  • Renal insufficiency (serum creatinine and potassium must be within normal limits)
  • Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days)
  • Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
  • Hypersensitivity to active ingredients

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Investigative Clinical Research

    Annapolis, Maryland

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana

  • Gastroenterology Research Consultants of Greater Cincinnati

    Cincinnati, Ohio

  • Florida Clinical Research Group

    Clearwater, Florida

  • Vital re:Search, Inc

    Greensboro, North Carolina

  • Investigational site

    Hollywood, Florida

  • Nature Coast Clinical Research

    Inverness, Florida

  • Gastroenterology Associates

    Kingsport, Tennessee

  • NJ Physicians, LLC

    Passaic, New Jersey

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania

  • Louisiana Research Center

    Shreveport, Louisiana

Other trials in United States

About this study

Official title: A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of "Day Before" PicoPrep™ for Oral Administration Versus HalfLytely® for Colon Cleansing in Preparation for Colonoscopy

Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.

Being tested
PicoPrep, HalfLytely, bisacodyl
Keywords
Bowel Preparation, Colonoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PicoPrepDrug

    Also called PicoPrep™, Prepopik™

    PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy.

  • HalfLytelyDrug

    HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.

  • bisacodylDrug

    Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

Study groups in NCT01073943
Study groupRoleWhat they receive
PicoPrepExperimental"Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy.
Receives: Drug: PicoPrep
HalfLytelyActive comparatorHalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Receives: Drug: HalfLytely; Drug: bisacodyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist

    Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.

    Measured: Day 2

Secondary outcomes (8)

  1. Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist

    Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.

    Measured: Day 2

  2. Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?

    Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult

    Measured: Day 2

  3. Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?

    Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no

    Measured: Day 2

  4. Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation

    Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad

    Measured: Day 2

  5. Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was

    Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad

    Measured: Day 2

  6. Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?

    Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no

    Measured: Day 2

  7. Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?

    Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no

    Measured: Day 2

  8. Participants With Treatment-Emergent Adverse Events (TEAEs)

    Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.

    Measured: up to one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01073943
Sponsor's protocol ID
2009-02
Status last verified
Oct 2012
First submitted
22 Feb 2010
Last updated
30 Oct 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PicoPrep, HalfLytely and bisacodyl in people with Bowel Preparation, run by Ferring Pharmaceuticals at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist (time frame: Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01073943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in