Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Survey of Prevalence of Loss of Appetite in Subject With Health Disorders (SPLASH)

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 13, 2012
Last updated: February 10, 2015
Last verified: February 2015

April 13, 2012
February 10, 2015
May 2012
March 2014   (final data collection date for primary outcome measure)
Percentage of patients with loss of appetite [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01592149 on Archive Site
  • Percentage of patients with fatigue [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Distribution of fatigue among the patients with respect to disease [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Percentage of patients with moderate to very severe Fatigue. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders.

The study is an epidemiological survey to find out the incidence of loss of appetite in Indian patients suffering from various health disorders. This survey will be conducted to obtain information on appetite from a total of 17500 subjects This study does not intend to study the effect of any drugs. The primary source of information will be the subjects themselves. The study will be conducted at 275 - 350 centres spread across India.This is a single visit study.The physician will conduct routine clinical, physical and general examination.

Not Provided
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
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Probability Sample

Patient with various health related disoder

Other: No Drug
No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.
Group 1
Intervention: Other: No Drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2015
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and Non-pregnant women ≥ 18 years of age recuperating from healthcare disorders like:Malaria fever, Typhoid or enteric fever
  • Hepatitis
  • Acute infections including respiratory, urinary tract infections etc treated with antibiotic
  • Tuberculosis
  • Patient discharged from hospital after general surgical procedures like acute appendectomy, etc.
  • Any other condition

Exclusion Criteria:

  • Patients unwilling to provide informed consent & comply with the study procedure
  • Patient using drugs which affect appetite like Cyproheptadine etc.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Study Director: Bayer Study Director Bayer
February 2015

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