Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial
NCT ID: NCT07215000
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2025-10-01
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This project will be conducted over a 12-month period and seeks to compare patient experience of both preparation methods in an outpatient setting. The study will evaluate the rate of preparation completion, patient satisfaction, tolerance of the solutions, and the endoscopic adequacy of each method.
Eligible participants are patients aged 18 or older with upcoming colonoscopy appointments who can provide informed consent in English or Spanish. There is no health risks associated with this study, as both bowel preparation methods are FDA-approved and commonly used in clinical practice.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Clenpiq vs Golytely Bowel Preparation
NCT03198221
Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening
NCT02523911
Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
NCT00611442
Comparing 4L Golytely to 2L Golytely With 15mg Bisacodyl Regimens for Inpatient Colonic Preparation
NCT01452737
Safety and Efficacy of CDFR0612 and CDFR0613 for Bowel Cleansing Before Colonoscopy
NCT02304523
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Golytely
GoLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLYTELY cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear.
Golytely
large volume liquid prep.
Sulfave
Suflave is a combination, osmotic prescription laxative that may be used to cleanse the bowel in preparation for colonoscopy in adults. Suflave contains polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride, and is supplied as a powder that is mixed with a low volume of water before consuming. It tastes like a lemon-lime sports drink. Drink 8 ounces of the solution every 15 minutes until the bottle is empty, and then drink an additional 16 ounces of water during the evening. One dose of Suflave is equal to one bottle plus one flavor-enhancing packet.
Sulfave
SUFLAVE is a split-dose (2-day) regimen. A total of 2 bottles are required for complete preparation for colonoscopy. You will take 2 bottles of liquid in two separate doses. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.
Sutab
SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.
Sutab
SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Golytely
large volume liquid prep.
Sulfave
SUFLAVE is a split-dose (2-day) regimen. A total of 2 bottles are required for complete preparation for colonoscopy. You will take 2 bottles of liquid in two separate doses. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.
Sutab
SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Morehouse School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jesus M Luevano, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Morehouse School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Morehouse School of Medicine
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Averous M. [Results of early surgery of obstructive uropathies diagnosed prenatally: apropos of 56 cases]. Acta Urol Belg. 1989;57(2):423-30. No abstract available. French.
Niikawa N, Ishikiriyama S, Shikimani T. The "Michelin tire baby" syndrome--an autosomal dominant trait. Am J Med Genet. 1985 Nov;22(3):637-8. doi: 10.1002/ajmg.1320220327. No abstract available.
Ito F, Harada Y. Responses of muscle spindle and leaflike receptor afferents to sinusoidal stretching. Am J Physiol. 1972 Nov;223(5):1246-9. doi: 10.1152/ajplegacy.1972.223.5.1246. No abstract available.
Adamski GB, Garin EH, Ballinger WE, Shulman ST. Generalized nonsuppurative myositis with staphylococcal septicemia. J Pediatr. 1980 Apr;96(4):694-7. doi: 10.1016/s0022-3476(80)80745-1. No abstract available.
Jaric MV. Long-range icosahedral orientational order and quasicrystals. Phys Rev Lett. 1985 Aug 5;55(6):607-610. doi: 10.1103/PhysRevLett.55.607. No abstract available.
Vemulapalli KC, Lahr RE, Rex DK. 2021 Patient Perceptions Regarding Colonoscopy Experience. J Clin Gastroenterol. 2023 Apr 1;57(4):400-403. doi: 10.1097/MCG.0000000000001689.
Chien C, Morimoto LM, Tom J, Li CI. Differences in colorectal carcinoma stage and survival by race and ethnicity. Cancer. 2005 Aug 1;104(3):629-39. doi: 10.1002/cncr.21204.
Miller JS, Cervenka T, Lund J, Okazaki IJ, Moss J. Purine metabolites suppress proliferation of human NK cells through a lineage-specific purine receptor. J Immunol. 1999 Jun 15;162(12):7376-82.
Wilson NI, Dreghorn CR. Costs of prophylaxis in joint prosthesis. Br Med J (Clin Res Ed). 1988 Feb 13;296(6620):499. No abstract available.
Freer JH, Levinson HS. Fine structure of Bacillus megaterium during microcycle sporogenesis. J Bacteriol. 1967 Aug;94(2):441-57. doi: 10.1128/jb.94.2.441-457.1967.
Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2282829
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.