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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01010191
Recruitment Status : Completed
First Posted : November 9, 2009
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
Harvard University Faculty of Medicine

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 9, 2009
Last Update Posted Date June 22, 2011
Study Start Date  ICMJE July 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2009)		 IBS Global Improvement Scale [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2009)
  • IBS Adequate Relief [ Time Frame: 3 weeks ]
  • IBS quality of life (QoL) [ Time Frame: 3 weeks ]
  • IBS Symptom Severity Scale [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Official Title  ICMJE Pilot Randomized Controlled Trial
Brief Summary Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE Other: Sugar pill
Study Arms  ICMJE
  • Experimental: Cellulose pill
    The active intervention is a sugar pill.
    Intervention: Other: Sugar pill
  • No Intervention: No treatment
    The control arm is wait list control
Publications * Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 6, 2009)		 70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Irritable bowel syndrome.

Exclusion Criteria:

  • Any signs of organic bowel disease such as rectal bleeding.
  • No other major illnesses.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01010191
Other Study ID Numbers  ICMJE M16986
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ted Kaptchuk, Harvard Medical School
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Harvard University Faculty of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Beth Israel Deaconess Medical Center
Investigators  ICMJE Not Provided
PRS Account Harvard University Faculty of Medicine
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP