AppetiteSPLASHNCT01592149
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders
An observational study of Appetite, run by Bayer at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appetite
- What is being tested?
- No Drug
- How many people
- 16,629 participants
- Where
- 1 siteIndia
- Study dates
- May 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with various health related disoder
Who may be able to join
- 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
Who cannot join
- Patients unwilling to provide informed consent \& comply with the study procedure
- Patient using drugs which affect appetite like Cyproheptadine etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Appetite
- Being tested
- No Drug
- Keywords
- Appetite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No DrugOther
No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: No Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with loss of appetite
Measured: 1 Day
Secondary outcomes (3)
Percentage of patients with fatigue
Measured: 1 Day
Distribution of fatigue among the patients with respect to disease
Measured: 1 Day
Percentage of patients with moderate to very severe Fatigue.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 16,629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592149
- Sponsor's protocol ID
- 16235
- Acronym
- SPLASH
- Status last verified
- Feb 2015
- First submitted
- 13 Apr 2012
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Prevalence of Loss of Appetite in Subject With Health Disorders.
- ClinicalTrials.gov ID
- NCT01592149
- Acronym / sponsor ID
- SPLASH / 16235
- Conditions
- Appetite
- Keywords
- Appetite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,629 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with various health related disoder
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients unwilling to provide informed consent \& comply with the study procedure
- Patient using drugs which affect appetite like Cyproheptadine etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No DrugNo intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders. | Other | Group 1 |
Primary outcome
Percentage of patients with loss of appetite
Time frame: 1 Day
3 secondary outcomes
Percentage of patients with fatigue
Time frame: 1 Day
Distribution of fatigue among the patients with respect to disease
Time frame: 1 Day
Percentage of patients with moderate to very severe Fatigue.
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appetite, run by Bayer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with loss of appetite (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.