The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing

NCT ID: NCT02618564

Last Updated: 2018-05-09

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy Preparation Outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2 TABS QHS

Sennosides 2 tabs, taken two nights before the colonoscopy

Group Type ACTIVE_COMPARATOR

Sennosides

Intervention Type DRUG

Each group will be assigned different doses of sennosides and varying times of administration

3 TABS QHS

Sennosides 3 tabs, taken two nights before the colonoscopy

Group Type ACTIVE_COMPARATOR

Sennosides

Intervention Type DRUG

Each group will be assigned different doses of sennosides and varying times of administration

2 TABS AM

Sennosides 2 tabs, taken the morning before the colonoscopy

Group Type ACTIVE_COMPARATOR

Sennosides

Intervention Type DRUG

Each group will be assigned different doses of sennosides and varying times of administration

3 TABS AM

Sennosides 3 tabs, taken the morning before the colonoscopy

Group Type ACTIVE_COMPARATOR

Sennosides

Intervention Type DRUG

Each group will be assigned different doses of sennosides and varying times of administration

2 TABS AM & QHS

Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy.

Group Type ACTIVE_COMPARATOR

Sennosides

Intervention Type DRUG

Each group will be assigned different doses of sennosides and varying times of administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sennosides

Each group will be assigned different doses of sennosides and varying times of administration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Senokot

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and non-pregnant female patients 18 to 75 years of age inclusive
* Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep

Exclusion Criteria

* Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG)
* Ileus or bowel obstruction
* Previous colorectal surgery
* Ascites
* Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment)
* Pregnancy
* Recent (\<6 months) myocardial infarction or unstable angina.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queen's University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Lawrence Hookey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lawrence Hookey

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hotel Dieu Hospital

Kingston, Ontario, Canada

Site Status

Hotel Dieu Hospital

Kingston, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DMED#1845-15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multi-centre Failed Bowel Prep RCT
NCT02976805 COMPLETED PHASE3