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

October 27, 2010 updated by: Inje University
: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-030
        • Inje University School of Medicine, Haeundae Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Solin Oral (Korea Pharma., Seoul, Korea)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inje University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

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  • HGI-2010-01

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