- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229800
Efficacy, Safety and Tolerability of Split-dose of PEG Compared With NaP Solution for Colonoscopy Preparation: A Randomized, Controlled Trial (SPEN)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study design: Investigator-blinded, prospective, randomized controlled trial
Subjects
- Entry criteria: Adult outpatients(at least 18 years of age, under 65 years) who undergo scheduled colonoscopy for screening, cancer surveillance or want procedure with/without non-specific gastrointestinal symptoms.
- Exclusion criteria:
age under 18 years, elderly patients(>65 yrs), pregnancy, breast feeding, patient with bowel obstruction, and other structural intestinal disorders, gut hypomotility(chronic constipation(< 2 bowel movement/week for 1yr), hypomotility syndrome, megacolon, idiopathic pseudoobstruction), renal failure, congestive heart failure, liver failure, pre-existing electrolyte disturbance(hypercalcemia, hyperphosphatemia); refusal of consent to participate in the study.
Sampling design: Consecutive recruitment of consenting patients
Variables Predictor: split dose of PEG and sodium phosphate Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect) Confounding variables: age, gender, BMI, experience of colonoscopy, surgical history, bowel movement, comorbidity, indication, presence of GI symptoms, medication
Statistical issues
Hypothesis: Split dose bowel preparation with PEG will provide a better quality preparation and similar tolerability than that with sodium phosphate for morning colonoscopy.
Sample size.: Improving rate 20% in bowel cleansing efficacy(Ottawa scale), study power 80%, alpha-error(level of significance, P-value) 5%, mean value scale=5, effect size 1, SD=2.5-> sample size= 100/100
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Busan, Korea, Republic of, 612-030
- Inje University School of Medicine, Haeundae Paik Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult outpatients(at least 18 years of age, under 65 years) who undergo scheduled colonoscopy for screening, cancer surveillance or want procedure with/without non-specific gastrointestinal symptoms
Exclusion Criteria:
- age under 18 years, elderly patients(>,=65 yrs), pregnancy, breast feeding, patient with bowel obstruction, and other structural intestinal disorders, gut hypomotility(chronic constipation(< 2 bowel movement/week for 1yr), hypomotility syndrome, megacolon, idiopathic pseudoobstruction), renal failure, congestive heart failure, liver failure, pre-existing electrolyte disturbance(hypercalcemia, hyperphosphatemia); refusal of consent to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Split dose PEG
Group 1 (split-dose PEG regimen; Colyte, Taejoon Pharmaceuticals, Seoul, Korea; 236g PEG, 22.74g Na2SO4, 6.74g NaHCO3, 5.86g NaCl, and 2.97g KCl) ingested 2 liters of PEG at 6 PM on the day before the procedure and the remaining 2 liters in the early morning at least 2 hours prior to the procedure.
Patients were instructed to take PEG 250 ml every ten minutes.
|
Group 1 (split-dose PEG regimen; Colyte, Taejoon Pharmaceuticals, Seoul, Korea; 236g PEG, 22.74g Na2SO4, 6.74g NaHCO3, 5.86g NaCl, and 2.97g KCl) ingested 2 liters of PEG at 6 PM on the day before the procedure and the remaining 2 liters in the early morning at least 2 hours prior to the procedure.
Patients were instructed to take PEG 250 ml every ten minutes.
Group 2 (NaP regimen; Solin Oral, Korea Pharma., Seoul, Korea; 48g NaH2PO4 monosodium phosphate, 18g Na2HPO4 disodium phosphate) ingested 45ml NaP solution at 6 PM on the day before the procedure and remaining 45ml of NaP solution, separated temporally by minimum of 10 to 12 hours, at least 2 hours prior to the colonoscopy on the day of the procedure.
Other Names:
|
ACTIVE_COMPARATOR: Sodium phosphate(NaP) solution
Group 2 (NaP regimen; Solin Oral, Korea Pharma., Seoul, Korea; 48g NaH2PO4 monosodium phosphate, 18g Na2HPO4 disodium phosphate) ingested 45ml NaP solution at 6 PM on the day before the procedure and remaining 45ml of NaP solution, separated temporally by minimum of 10 to 12 hours, at least 2 hours prior to the colonoscopy on the day of the procedure.
Patients taking NaP solution were instructed to drink a minimum 1L of clear liquids during the evening on the day before the procedure and were encouraged to consume additional clear liquids.
|
Group 2 (NaP regimen; Solin Oral, Korea Pharma., Seoul, Korea; 48g NaH2PO4 monosodium phosphate, 18g Na2HPO4 disodium phosphate) ingested 45ml NaP solution at 6 PM on the day before the procedure and remaining 45ml of NaP solution, separated temporally by minimum of 10 to 12 hours, at least 2 hours prior to the colonoscopy on the day of the procedure.
Patients taking NaP solution were instructed to drink a minimum 1L of clear liquids during the evening on the day before the procedure and were encouraged to consume additional clear liquids.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of bowel preparation
Time Frame: Between August and October 2010.
|
The primary end point of the study was to assess the quality of bowel preparation according to the Ottawa scale including cleanliness and fluid quantity.
|
Between August and October 2010.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of bowel preparation
Time Frame: Between August and October 2010
|
The secondary end points included patient tolerability and safety of bowel preparation using patient questionnaire consisted of compliance, acceptance, preference and adverse events such as abdominal pain and bloating, nausea and vomiting, headache and dizziness, sleep disturbance.
|
Between August and October 2010
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tae Oh Kim, M.D., PhD, Inje University School of Medicine, Haeundae Paik Hospital
- Principal Investigator: Eun Hee Seo, M.D., Inje University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HGI-2010-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bowel Preparation, Efficacy, Tolerability, Safety
-
University of British ColumbiaCompletedEfficacy of Bowel Preparation | Ease of Bowel Preparation and Patient TolerabilityCanada
-
Sichuan Huiyu Pharmaceutical Co., LtdRecruitingEfficacy | Tolerability | SafetyChina
-
Medigene AGTerminatedFeasibility | Tolerability | Safety | Treatment EfficacyGermany
-
Sorbent TherapeuticsCompletedBasic Science: Safety, Tolerability, Efficacy of CLPUnited States
-
Karolinska InstitutetCompletedPatient Satisfaction and Efficacy of Bowel-preparationSweden
-
Getz PharmaPrimary Care Diabetes Association, PakistanRecruitingEfficacy | Tolerability | SafetyPakistan
-
AnaMar ABCovanceCompletedTolerability | SafetyUnited Kingdom
-
JemincareRecruitingSafety and TolerabilityChina
-
Island PharmaceuticalsBeyond Drug DevelopmentCompletedSafety and TolerabilityAustralia
-
Usona InstituteCompletedPharmacokinetics | Tolerability | SafetyUnited States
Clinical Trials on Polyethylene glycol
-
Changhai HospitalUnknownAdenoma Detection Rate | Bowel Preparation ScaleChina
-
Cook County HealthCompletedBowel Preparation for ColonoscopyUnited States
-
Cleveland Clinic FloridaCompletedColon CancerUnited States
-
Oregon Health and Science UniversityUnknownColonoscopyUnited States
-
Air Force Military Medical University, ChinaCompletedColonoscopy | Bowel Preparation | Predictive ModelChina
-
Shandong UniversityCompleted
-
Instituto Mexicano del Seguro SocialCompleted
-
Incheon St.Mary's HospitalCompletedUnrecognized ConditionKorea, Republic of
-
Jiangsu HengRui Medicine Co., Ltd.Beijing Tongren HospitalCompleted
-
Medical University of WarsawUnknown