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Trial record 26 of 33777 for:    Placebo AND placebo effect

Effects of Open-label vs Double-blind Treatment in 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: NCT02802241
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 16, 2016
Last Update Posted Date February 27, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
IBS-SSS [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT02802241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Open-label vs Double-blind Treatment in IBS
Official Title  ICMJE Effects of Open-label vs Double-blind Treatment in IBS
Brief Summary The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Placebo Effect
  • Placebos
  • Peppermint Oil
Intervention  ICMJE
  • Drug: placebo
  • Dietary Supplement: peppermint oil
Study Arms  ICMJE
  • Experimental: open-label placebo
    Intervention: Drug: placebo
  • Experimental: double-blind placebo
    Intervention: Drug: placebo
  • Experimental: double-blind peppermint oil
    Intervention: Dietary Supplement: peppermint oil
  • No Intervention: no additional treatment
Publications * Ballou S, Kaptchuk TJ, Hirsch W, Nee J, Iturrino J, Hall KT, Kelley JM, Cheng V, Kirsch I, Jacobson E, Conboy L, Lembo A, Davis RB. Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial. Trials. 2017 May 25;18(1):234. doi: 10.1186/s13063-017-1964-x.

*   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
Actual Enrollment  ICMJE
 (submitted: February 26, 2019)
340
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
280
Actual Study Completion Date  ICMJE January 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meet Rome IV diagnostic criteria for IBS
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT02802241
Other Study ID Numbers  ICMJE 2015P000282
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony Lembo, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Anthony Lembo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date February 2019

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