Survey of Prevalence of Loss of Appetite in Subject With... | NCT01592149

Studies
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders

NCT01592149

Sponsor

Bayer

Status

Completed

Last Update Posted

Feb 11, 2015Estimated

Enrollment

16,629Actual

Phase

Not provided

Conditions

Appetite

Interventions

No Drug

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Apr 13, 2012

First Submission Date that Met QC Criteria

May 3, 2012

First Posted Date

May 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2015

Last Update Posted Date

Feb 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16,629Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Other: No Drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Drug	Other	No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with loss of appetite		1 Day

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients with fatigue		1 Day
Distribution of fatigue among the patients with respect to disease		1 Day
Percentage of patients with moderate to very severe Fatigue.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with various health related disoder

Sampling Method

Probability Sample