NCT00372970

Brief Summary

It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

June 9, 2015

Completed
Last Updated

June 9, 2015

Status Verified

May 1, 2015

Enrollment Period

5.4 years

First QC Date

September 5, 2006

Results QC Date

April 16, 2015

Last Update Submit

May 19, 2015

Conditions

Gastroparesis

Keywords

gastroparesisvomitingnauseabloatingdyspepsia

Outcome Measures

Primary Outcomes (1)

  • Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.

    Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be \>=27. In a previous study internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores.

    1 month

Study Arms (2)

Botulinum Toxin A

ACTIVE COMPARATOR

200 U of Botox injected endoscopically into pylorus

Drug: Botulinum toxin A

Placebo

PLACEBO COMPARATOR

saline into pylorus.

Drug: Placebo

Interventions

Botulinum toxin ADRUG

200 U given by injection into the pylorus.

Also known as: Botox into pylorus
Botulinum Toxin A
PlaceboDRUG

saline injection into pylorus.

Also known as: saline injection into pylorus
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented gastroparesis by radiologic study
  • No ulcer disease
  • Only surgery history must be either appendectomy or cholecystectomy
  • No prior treatment with Botox

You may not qualify if:

  • Prior botox injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • Friedenberg FK, Palit A, Parkman HP, Hanlon A, Nelson DB. Botulinum toxin A for the treatment of delayed gastric emptying. Am J Gastroenterol. 2008 Feb;103(2):416-23. doi: 10.1111/j.1572-0241.2007.01676.x. Epub 2007 Dec 5.

    PMID: 18070232RESULT

MeSH Terms

Conditions

GastroparesisVomitingNauseaDyspepsia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Frank Friedenberg
Organization
Temple University
frank.friedenberg@temple.edu
215-707-9900

Study Officials

  • Frank K Friedenberg, MD

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

July 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 9, 2015

Results First Posted

June 9, 2015

Record last verified: 2015-05

Locations

US(1)