NCT00372970 is a NA clinical trial of Botulinum toxin A in Gastroparesis, sponsored by Temple University.

Who is sponsoring NCT00372970?

NCT00372970 is sponsored by Temple University.

What drugs are being tested in NCT00372970?

Interventions in NCT00372970: Botulinum toxin A, Placebo.

What condition does NCT00372970 study?

NCT00372970 studies Gastroparesis.

Is NCT00372970 still recruiting?

NCT00372970 is currently completed. Last updated 19 May 2015.

Are results published for NCT00372970?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-05-19 · How we verify

NCT00372970

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Randomized Placebo-Controlled Double Blind Study of Botulinum Toxin Versus Placebo for the Treatment of Gastroparesis

Completed NA Results posted Last updated 19 May 2015

What this trial tests

NA trial testing Botulinum toxin A in Gastroparesis in 32 participants. Completed in 1 December 2008.

Timeline

1 July 2003

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	Temple University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	32
Start date	1 July 2003
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	1 location across United States

Drugs / interventions tested

Botulinum toxin A — full drug profile →
Placebo

Conditions studied

Gastroparesis — all drugs for Gastroparesis →

Sponsor

Temple University

Who can join

Adults 18 to 70, any sex, with Gastroparesis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.
Time frame: 1 month
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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Botulinum toxin A

Trials testing the same drug.

NCT06583590 — Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction · Phase 2, PHASE3 · recruiting
NCT06470581 — Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A · NA · not yet recruiting
NCT06814288 — The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment · Phase 2 · active not recruiting
NCT06315790 — Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia · Phase 3 · unknown
NCT06878482 — Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease · Phase 4 · recruiting

Other recruiting trials for Gastroparesis

Currently open trials in the same condition.

NCT04661215 — Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms · recruiting
NCT07104214 — Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy · recruiting
NCT07526935 — Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator · NA · active not recruiting
NCT05981300 — GpCRC Pediatric Gastroparesis Registry 2 · recruiting
NCT06580197 — The Role of AAT After Abdominal Surgery Based on RWS · recruiting

Other Temple University trials

Trials by the same sponsor.

NCT07055360 — A Trauma-Informed Intervention for the Newly HIV-Diagnosed · NA · not yet recruiting
NCT07277816 — Photo-experiencing and Reflective Listening (PEARL) to Promote Healing Engagement for Survivors of Violence · NA · recruiting
NCT07151768 — Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension · recruiting
NCT07027865 — Sip and Snack Better (SSB) Study: Improving Added Sugar in Adolescents · NA · active not recruiting
NCT06810557 — Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00372970 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Temple University
Last refreshed: 19 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00372970.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing