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

NCT00902031 | Completed

• 2 other identifiers: G599001036G517000014
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Constipation; Palliative Care

Keywords

Docusate; Constipation; Colace; Palliative Care; Sennoside; Senokot; Terminally Ill; Stool; Randomized Trial

Outcome Measures

Primary Outcomes (5)

• Stool Frequency

  10 days

• Stool Consistency

  10 day

• Difficulty Defecating

  10 day

• Symptoms Related to Constipation (pain, nausea, appetite loss, abdominal discomfort, shortness of breath)

  10 day

• Type of Additional Bowel Care Interventions which may be Required

  10 days

Study Arms (2)

Docusate + Sennoside

EXPERIMENTAL

Drug: Docusate Sodium, Sennoside

Sennoside + Placebo

PLACEBO COMPARATOR

Drug: Sennoside + Placebo

Interventions

Docusate Sodium, Sennoside DRUG

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.

Also known as: Colace, Senokot

Docusate + Sennoside

Sennoside + Placebo DRUG

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

Also known as: Senokot

Sennoside + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Alberta: lead
• College of Family Physicians of Canada: collaborator
• Covenant Health, Canada: collaborator
• Capital Care: collaborator

Study Sites (3)

CapitalCare Norwood

Edmonton, Alberta, T5G 3A2, Canada

Location

Mel Miller Hospice at Edmonton General Continuing Care Hospital

Edmonton, Alberta, T5K 0A1, Canada

Location

St. Joseph's Auxiliary Care Hospital

Edmonton, Alberta, T6J 6W1, Canada

Location

Related Publications (5)

• CASS LJ, FREDERIK WS. Doxinate in the treatment of constipation. Am J Gastroenterol. 1956 Dec;26(6):691-8. No abstract available.

  PMID: 13372512 BACKGROUND

• Castle SC, Cantrell M, Israel DS, Samuelson MJ. Constipation prevention: empiric use of stool softeners questioned. Geriatrics. 1991 Nov;46(11):84-6. No abstract available.

  PMID: 1718823 BACKGROUND

• Fain AM, Susat R, Herring M, Dorton K. Treatment of constipation in geriatric and chronically ill patients: a comparison. South Med J. 1978 Jun;71(6):677-80. doi: 10.1097/00007611-197806000-00022.

  PMID: 78527 BACKGROUND

• Goodman J, Pang J, Bessman AN. Dioctyl sodium sulfosuccinate- an ineffective prophylactic laxative. J Chronic Dis. 1976 Jan;29(1):59-63. doi: 10.1016/0021-9681(76)90068-0. No abstract available.

  PMID: 1254685 BACKGROUND

• Hurdon V, Viola R, Schroder C. How useful is docusate in patients at risk for constipation? A systematic review of the evidence in the chronically ill. J Pain Symptom Manage. 2000 Feb;19(2):130-6. doi: 10.1016/s0885-3924(99)00157-8.

  PMID: 10699540 BACKGROUND

MeSH Terms

Conditions

Constipation

Interventions

Dioctyl Sulfosuccinic Acid; Sennosides

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Richard Spooner, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Yoko Tarumi, MD

  University of Alberta/Regional Palliatvie Care Program (Capital Health)

  PRINCIPAL INVESTIGATOR

• Olga Szafran, MSc.

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: April 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 20, 2011

Record last verified: 2011-04

Locations

CA (3)