Efficacy, Safety and Tolerability of Split-dose of PEG Compared With NaP Solution for Colonoscopy Preparation: A Randomized, Controlled Trial (SPEN)

This study has been completed.
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT01229800
First received: October 27, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

: In several studies comparing of sodium phosphate solutions versus PEG, both regimen had similar efficacy of bowel cleansing and sodium phosphate solutions are more acceptable to patients because patient are required to consume smaller volume. But sodium phosphate solutions are associated with fluid and electrolyte disturbances, so use of sodium phosphate solution in routine medical check-up of outpatients is problematic. PEG can provide a rapid peroral approach to colon lavage without causing fluid and electrolyte disturbance. However, the need to ingest a large volume of fluid reduces patient compliance, and results in suboptimal bowel preparation. In order to overcome this disadvantage, several studies proved that split dose of PEG regimens were better quality preparation and more acceptable than single dose regimens. In Korea, need for outpatient or screening colonoscopy without laboratory test is increasing and split dose of PEG is used more frequently than other country in bowel preparation because of safety. But, superiority of split dose of PEG to sodium phosphate solution has not been demonstrated. The study was not yet existed about comparison of split dose PEG solution with sodium phosphate solution for bowel cleansing and tolerability in colonoscopy preparation. To use split dose of PEG in bowel preparation with medical evidence, we want to demonstrate split dose bowel preparation with PEG compared to sodium phosphate solutions provide a better colon cleansing efficacy and similar tolerability.


Condition Intervention Phase
Bowel Preparation, Efficacy, Tolerability, Safety
Drug: Polyethylene glycol
Drug: Sodium phosphate(NaP) solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Efficacy, Safety and Tolerability of Split-dose of PEG Compared With NaP Solution for Colonoscopy Preparation: A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Efficacy of bowel preparation [ Time Frame: Between August and October 2010. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Safety and tolerability of bowel preparation [ Time Frame: Between August and October 2010 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 207
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Polyethylene glycol
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 Name: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
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.
Drug: 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.
Other Name: Solin Oral (Korea Pharma., Seoul, Korea)

Detailed Description:

Study design: Investigator-blinded, prospective, randomized controlled trial

Subjects

  1. 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.
  2. 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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01229800

Locations
Korea, Republic of
Inje University School of Medicine, Haeundae Paik Hospital
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
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
  More Information

No publications provided by Inje University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tae Oh Kim, Haeundae Paik Hospital, Inje University School of Medicine
ClinicalTrials.gov Identifier: NCT01229800     History of Changes
Other Study ID Numbers: HGI-2010-01
Study First Received: October 27, 2010
Last Updated: October 27, 2010
Health Authority: Korea(South): Korea Food and Drug Administration

Keywords provided by Inje University:
Polyethylene Glycol, Sodium Phosphate, Bowel preparation, Efficacy

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014