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

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ClinicalTrials.gov Identifier: NCT00902031
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : April 20, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if docusate is effective in the treatment of constipation in palliative care patients.

Condition or disease Intervention/treatment
Constipation Palliative Care Drug: Docusate Sodium, Sennoside Drug: Sennoside + Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of Oral Docusate for Preventing/Treating Constipation in Palliative Care Patients.
Study Start Date : April 2006
Primary Completion Date : October 2010
Study Completion Date : October 2010


Arms and Interventions

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:
  • Colace
  • Senokot
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 Name: Senokot


Outcome Measures

Primary Outcome Measures :
  1. Stool Frequency [ Time Frame: 10 days ]
  2. Stool Consistency [ Time Frame: 10 day ]
  3. Difficulty Defecating [ Time Frame: 10 day ]
  4. Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath) [ Time Frame: 10 day ]
  5. Type of Additional Bowel Care Interventions which may be Required [ Time Frame: 10 days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902031


Locations
Canada, Alberta
CapitalCare Norwood
Edmonton, Alberta, Canada, T5G 3A2
Mel Miller Hospice at Edmonton General Continuing Care Hospital
Edmonton, Alberta, Canada, T5K 0A1
St. Joseph's Auxiliary Care Hospital
Edmonton, Alberta, Canada, T6J 6W1
Sponsors and Collaborators
University of Alberta
College of Family Physicians of Canada (Janus Research Grant)
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
More Information

Publications:
Responsible Party: Dr. Richard Spooner, University of Alberta
ClinicalTrials.gov Identifier: NCT00902031     History of Changes
Other Study ID Numbers: G599001036
G517000014
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: April 2011

Keywords provided by University of Alberta:
Docusate
Constipation
Colace
Palliative Care
Sennoside
Senokot
Terminally Ill
Stool
Randomized Trial

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bismuth subsalicylate
Sennoside A&B
Senna Extract
Antidiarrheals
Gastrointestinal Agents
Cathartics