BLI800
DrugSolution for oral administration prior to colonoscopy
NCT Number: NCT00856843
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
University of South Alabama, Mobile, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Solution for oral administration prior to colonoscopy
Solution for oral administration prior to colonoscopy
Time frame: 2 days
Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.
Time frame: 2 days
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).
Time frame: up to 15 days
Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.
Time frame: up to 15 days
Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.
Braintree Laboratories
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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