Ghrelin - A Possible Opportunity to Improve Appetite | NCT00681486

Studies
Ghrelin - A Possible Opportunity to Improve Appetite

NCT00681486

Sponsor

Göteborg University

Status

Completed

Last Update Posted

Aug 21, 2009Estimated

Enrollment

30Estimated

Phase

Phase 3

Conditions

Cancer

Interventions

Ghrelin
Ghrelin

Countries

Sweden

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

Aug 2009

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

Oct 2003

Primary Completion Date

Jun 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

May 19, 2008

First Submission Date that Met QC Criteria

May 20, 2008

First Posted Date

May 21, 2008Estimated

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

Aug 20, 2009

Last Update Posted Date

Aug 21, 2009Estimated

Name	Class
Swedish Cancer Foundation	OTHER
Medical Research Council	OTHER_GOV

Description Module

Brief Summary

The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.

Detailed Description

Randomized study with follow up evaluations each month until preterminal state. Cancer patients will be randomised to either high dose or low dose of active treatment given as daily injection.

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A, 1	Active Comparator	Ghrelin	Drug: Ghrelin
A, 2	Active Comparator	Ghrelin.	Drug: Ghrelin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ghrelin	Drug	High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.	A, 1

Measure	Description	Time Frame
Food intake		June 2008

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Weight loss

Exclusion Criteria:

Diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kent Lundholm, MD, prof	Göteborg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of surgery, Sahlgrenska University Hospital		Gothenburg		413 45	Sweden

Label	URL
Göteborg University	View source

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054439	Ghrelin

Ancestor Terms

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided