Effectiveness of Docusate in Preventing/Treating Constipation in Palliative Care Patients

April 19, 2011 updated by: University of Alberta

Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients.

The purpose of this study is to determine if docusate is effective in the treatment of constipation in palliative care patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Palliative patients frequently experience constipation due to multiple factors - structural abnormalities, medications, metabolic disturbances, neurological disorders, and other general conditions. Docusate is a stool softener that has been widely used, in combination with other stimulating laxatives, to prevent and treat constipation in palliative care patients. In the past decade there has been controversy about its effectiveness in these populations, but no controlled trials have been conducted on the use of docusate in palliative patients. The purpose of this study is to assess the effectiveness of docusate in preventing and treating constipation in palliative care patients. The study design is a randomized, double-blind, placebo-controlled trial to compare the current standard treatment (docusate in combination with a laxative, sennoside) to that of a sennoside laxative alone. A total of 70 patients (35 in each group) will be recruited from the Palliative Care Unit at St. Joseph's Auxiliary Care Hospital, the Mel Miller Hospice at the Edmonton General Continuing Care Hospital, and CapitalCare Norwood in Edmonton, Alberta, Canada. Patients must be ≥ 18 years of age, able to take oral medication, without difficulty swallowing, have a palliative performance ≥ 20%, and do not have a stoma. The duration of treatment will be for 10 days. The main outcome measures will include bowel frequency, stool consistency, other interventions (suppositories, enemas), difficulty defecating, and sense of inability to evacuate completely. This study will provide insight into the effectiveness of docusate in preventing and treating constipation in palliative patients who are cared for by family physicians and specialized palliative care providers. If docusate is found to have no added benefit,it has the potential to enhance the quality of life for palliative care patients by reducing the number of medications taken and reducing the palliative care team's (e.g. nursing) workload and cost.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5G 3A2
        • CapitalCare Norwood
      • Edmonton, Alberta, Canada, T5K 0A1
        • Mel Miller Hospice at Edmonton General Continuing Care Hospital
      • Edmonton, Alberta, Canada, T6J 6W1
        • St. Joseph's Auxiliary Care 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • greater than or equal to 18 years of age
  • new admissions
  • able to take oral medications
  • patient and/or personal directive agent (proxy) provides written consent
  • does not have a stoma
  • no difficulty swallowing
  • no previous intolerance/contraindications to docusate
  • palliative performance greater than or equal to 20%

Exclusion Criteria:

  • less than 18 years of age
  • failing to provide consent
  • unable to take oral medication/difficulty swallowing
  • previous intolerance/contraindications to docusate (Colace)
  • patients who have a stoma
  • palliative performance status < 20%

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docusate + Sennoside
Drug: Docusate Sodium, Sennoside

Docusate sodium: given in capsule form (100 mg/capsule), at a dosage of 200 mg, taken twice daily for 10 days.

Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days.

Other Names:
  • Senokot
  • Colace
Placebo Comparator: Sennoside + Placebo
Drug: Sennoside + Placebo

Sennoside: will be given in tablet form (8.6 mg), 1-3 tablets taken 1-3 times daily for 10 days.

Placebo: will be taken in capsule form, similar in size, shape, and color to docusate, taken twice daily for 10 days

Other Names:
  • Senokot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stool Frequency
Time Frame: 10 days
10 days
Stool Consistency
Time Frame: 10 day
10 day
Difficulty Defecating
Time Frame: 10 day
10 day
Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath)
Time Frame: 10 day
10 day
Type of Additional Bowel Care Interventions which may be Required
Time Frame: 10 days
10 days

Collaborators and Investigators

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

Sponsor

University of Alberta

Collaborators

College of Family Physicians of Canada
Covenant Health
Capital Care

Investigators

  • Principal Investigator: Richard Spooner, MD, University of Alberta
  • Principal Investigator: Yoko Tarumi, MD, University of Alberta/Regional Palliatvie Care Program (Capital Health)
  • Study Director: Olga Szafran, MSc., University of Alberta

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

April 20, 2011

Last Update Submitted That Met QC Criteria

April 19, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G599001036
  • G517000014

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.

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