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Anal Dilatation for Infants and Children With Constipation

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: NCT02255747
Recruitment Status : Unknown
Verified September 2014 by Jiexiong Feng, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE September 28, 2014
First Posted Date  ICMJE October 3, 2014
Last Update Posted Date October 3, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
Daily stool times [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
  • The frequency of intestinal peristalsis waves [ Time Frame: two years ]
  • The amplitude of intestinal peristalsis waves [ Time Frame: two years ]
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 Anal Dilatation for Infants and Children With Constipation
Official Title  ICMJE Anal Dilatation for Infants and Children With Constipation
Brief Summary This study is to evaluate the effect of anal dilation in infants and children with constipation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE Drug: Lactulose
Study Arms  ICMJE
  • Active Comparator: anal dilatation
    Intervention: Drug: Lactulose
  • Active Comparator: Oral Lactulose
    Intervention: Drug: Lactulose
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 30, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Infants and Children With Constipation
  2. Postoperative infants and children with Hirschsprung's disease
  3. Good compliance

Exclusion Criteria:

  1. Infants and Children With Constipation
  2. Poor compliance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255747
Other Study ID Numbers  ICMJE Anal Dilatation
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiexiong Feng, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jiexiong, Feng Tongji Hospital
PRS Account Tongji Hospital
Verification Date September 2014

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