NCT02267525

Brief Summary

Study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. Three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. In addition, the study will be used to evaluate the psychometric properties of the Gastroparesis Rating Scale (GRS), a daily patient-reported outcome (PRO) measure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

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

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2.5 years

First QC Date

October 14, 2014

Last Update Submit

April 13, 2018

Conditions

Gastroparesis

Keywords

GastroparesisDiabeticIdiopathic

Outcome Measures

Primary Outcomes (1)

  • 7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score

    At Week 4

Secondary Outcomes (2)

  • Gastric emptying half-time

    At Week 4

  • Adverse events

    103 days

Study Arms (4)

Velusetrag 5mg

EXPERIMENTAL

Velusetrag 5mg capsules QD (once daily) x 12 weeks

Drug: Velusetrag

Velusetrag 15mg

EXPERIMENTAL

Velusetrag 15mg capsules QD x 12 weeks

Drug: Velusetrag

Velusetrag 30mg

EXPERIMENTAL

Velusetrag 30mg capsules QD x 12 weeks

Drug: Velusetrag

Placebo

PLACEBO COMPARATOR

Placebo capsules QD x 12 weeks

Drug: Placebo

Interventions

VelusetragDRUG
Also known as: TD-5108
Velusetrag 15mgVelusetrag 30mgVelusetrag 5mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
  • Composite score ≥2and \<5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the GCSI-2W) at Screening
  • Delayed gastric emptying by either GES (gastric emptying scintigraphy) or GEBT(gastric emptying breath test)
  • Upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms
  • Willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during Screening, if applicable; 24 hours prior to start of the Baseline period; and during the Baseline Period
  • GCSI-24H 7-day mean composite score ≥2.5 and \<5 at Day 1

You may not qualify if:

  • If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level \>11%
  • Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach
  • History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has functioning implantable electric stimulator
  • History of alcohol or drug abuse or dependence within the last year prior to Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abell TL, Kuo B, Esfandyari T, Pfeifer ND, Grimaldi M, Renzulli C, Tacchi R, Zhou K, Barnes CN, Nguyen DD, Nguyen L, Talley NJ, McCallum R. A randomized, double-blind, placebo-controlled, phase 2b study of the efficacy and safety of velusetrag in subjects with diabetic or idiopathic gastroparesis. Neurogastroenterol Motil. 2023 Apr;35(4):e14523. doi: 10.1111/nmo.14523. Epub 2023 Jan 9.

    PMID: 36624727DERIVED

MeSH Terms

Conditions

Gastroparesis

Interventions

TD-5108

Condition Hierarchy (Ancestors)

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

Study Officials

  • Deanna Nguyen, MD

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04