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NCT01010191 Clinical Trial

Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)

Irritable Bowel Syndrome Clinical Trial

Official title:
Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01010191
Other study ID # M16986
Secondary ID
Status Completed
Phase N/A
First received November 5, 2009
Last updated June 21, 2011
Start date July 2008
Est. completion date April 2010

Study information
Verified date June 2011
Source Harvard University Faculty of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

Description:

Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. The study will involve three visits: baseline, midpoint and end point. At baseline all patients will physical examination, be evaluated for IBS and be administered standardized IBS questionnaires including: "IBS adequate relief" questionnaire, IBS global symptom improvement scale, IBS quality of life and IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be administered. Patients on no treatment will be offered education on managing IBS at the end of the study.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Irritable bowel syndrome.

Exclusion Criteria:

- Any signs of organic bowel disease such as rectal bleeding.

- No other major illnesses.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Sugar pill

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Harvard University Faculty of Medicine Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary IBS Global Improvement Scale 3 weeks No
Secondary IBS Adequate Relief 3 weeks No
Secondary IBS quality of life (QoL) 3 weeks No
Secondary IBS Symptom Severity Scale 3 weeks No
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