Bowel Preparation for ColonoscopyNCT00611442
Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
A study testing lubiprostone in people with Bowel Preparation for Colonoscopy, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- lubiprostone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
- Ages will be from 18 years of age and older
Who cannot join
- Chronic kidney disease
- Previous diagnosis of congestive heart failure
- History of bowel obstruction
- History of solid organ transplant
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- lubiprostone, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lubiprostoneDrug
Also called amitiza
lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
placeboDrug
placebo gelcap, taken at noon the day prior to the colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment Receives: Drug: lubiprostone |
| 2 | Placebo comparator | split-dose PEG solution without dietary restrictions plus placebo pretreatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid
Measured: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
Secondary outcomes (3)
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.
Measured: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)
Procedure Time
Procedure time refers to the total length of time required to complete the colonoscopy
Measured: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
The Number of Polyps Detected on Examination
The number of colon polyps detected during the colonoscopy.
Measured: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Joel Z. Stengel, Brooke Army Medical Center
- Investigators
- Joel Z Stengel, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611442
- Sponsor's protocol ID
- C.2007.188
- Other IDs
- IND 78254
- Status last verified
- Oct 2012
- First submitted
- 29 Jan 2008
- Last updated
- 1 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002 Dec;97(12):3186-94. doi: 10.1111/j.1572-0241.2002.07129.x.
PubMed 12492209Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.
PubMed 16630226El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. doi: 10.1067/mge.2003.318.
PubMed 12838218Church JM. Effectiveness of polyethylene glycol antegrade gut lavage bowel preparation for colonoscopy--timing is the key! Dis Colon Rectum. 1998 Oct;41(10):1223-5. doi: 10.1007/BF02258217.
PubMed 9788383Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. doi: 10.1097/01.mcg.0000225665.68920.df.
PubMed 17413599
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00611442
- Acronym / sponsor ID
- C.2007.188
- Conditions
- Bowel Preparation for Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- Takeda
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Posted 1 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: lubiprostonesplit-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment |
| 2 | Placebo comparator | Drug: placebosplit-dose PEG solution without dietary restrictions plus placebo pretreatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
- Ages will be from 18 years of age and older
Key exclusion criteria (5 listed)
- Chronic kidney disease
- Previous diagnosis of congestive heart failure
- History of bowel obstruction
- History of solid organ transplant
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lubiprostoneAlso: amitizalubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy | Drug | 1 |
| placeboplacebo gelcap, taken at noon the day prior to the colonoscopy | Drug | 2 |
Primary outcome
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid
3 secondary outcomes
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
Time frame: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)
Procedure Time
Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
The Number of Polyps Detected on Examination
Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12492209Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002 Dec;97(12):3186-94. doi: 10.1111/j.1572-0241.2002.07129.x.
- Background: PubMed 16630226Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.
- Background: PubMed 12838218El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. doi: 10.1067/mge.2003.318.
- Background: PubMed 9788383Church JM. Effectiveness of polyethylene glycol antegrade gut lavage bowel preparation for colonoscopy--timing is the key! Dis Colon Rectum. 1998 Oct;41(10):1223-5. doi: 10.1007/BF02258217.
- Background: PubMed 17413599Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. doi: 10.1097/01.mcg.0000225665.68920.df.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Z Stengel, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lubiprostone in people with Bowel Preparation for Colonoscopy, run by Brooke Army Medical Center at 1 site 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 2 inclusion and 5 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 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 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?
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale (time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)). 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 NCT00611442, which also lists 5 linked publications.
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 1 Nov 2012.