Intragastric Injections of Botox for the Treatment of Obe... | NCT02035397

Studies
Intragastric Injections of Botox for the Treatment of Obesity

NCT02035397

Sponsor

Norwegian University of Science and Technology

Status

Unknown status

Last Update Posted

Oct 10, 2022Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Obesity, Morbid

Interventions

Botulinum Toxin Type A
Saline solution

Countries

Norway

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

ID	Type	Description	Link
2012-004381-18	EudraCT Number

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jan 12, 2014

First Submission Date that Met QC Criteria

Jan 12, 2014

First Posted Date

Jan 14, 2014Estimated

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

Oct 7, 2022

Last Update Posted Date

Oct 10, 2022Actual

Name	Class
St. Olavs Hospital	OTHER

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

One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.

There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Botulinum toxin A	Experimental	Botulinum toxin type A injection in muscles of stomach wall	Drug: Botulinum Toxin Type A
Saline solution	Placebo Comparator	Placebo (saline solution) injection first 6 months, then active treatment	Drug: Botulinum Toxin Type A Drug: Saline solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin Type A	Drug		Botulinum toxin A Saline solution	Botox

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body weight		Change from baseline to 6 months; 1 year; 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI > 35

Exclusion Criteria:

Known hypersensitivity to medication
Neuro muscular disease
Dysphagia
Tendency for aspiration
Ulcus
Use of aminoglycoside antibiotics and/or spectinomycin lately
Previous side effects of botox injections
Previous bariatric surgery
Previous cancer in GI-tract
Other obesity treatment last 12 months
Severe eating disorder
Hypothyroidism
Pregnancy/brest feeding
Reduced competence to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bård Kulseng, MD, PhD	Norwegian University of Science and Technology, Fac MH, IKOM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Olavs Hospital, Trondheim University Hospital		Trondheim		7006	Norway

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D015431	Weight Loss

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
D000077330	Saline Solution

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided