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GastroparesisPhase 2NCT01718938

Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis

A Phase 2 study testing velusetrag dose 1, velusetrag dose 2 and velusetrag dose 3 in people with Gastroparesis, run by Theravance Biopharma at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Gastroparesis
What is being tested?
velusetrag dose 1, velusetrag dose 2 and velusetrag dose 3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
9 sitesUnited States
Study dates
Dec 2012to Feb 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Symptoms of gastroparesis (e.g., nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening
  • Body Mass Index (BMI) between 18 and 35 kg/m2, inclusive
  • Gastroparesis Cardinal Symptom Index (GCSI-2W) composite score ≥2 and ≤4 at Screening
  • Delayed gastric emptying, defined as a gastric emptying half-time (GE t1/2) > 160 minutes as determined by [13C]-octanoate breath test, at Screening
  • Upper gastrointestinal (UGI) obstruction ruled out by endoscopy or other imaging reasonably proximal to the diagnosis of gastroparesis

Who cannot join

  • Acute severe gastroenteritis within 2 weeks prior to Screening
  • History of gastric outlet obstruction
  • Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication
  • Recurrent vomiting, defined as vomiting more than 2 days per week
  • Hospitalization for treatment of gastroparesis or complications of diabetes within 4 weeks prior to Screening
  • Presence of thyroid dysfunction not controlled by treatment. Subjects with abnormal thyroid stimulating hormone (TSH), hypothyroidism, or hyperthyroidism at Screening
  • If Type 1 or Type 2 diabetic, a glycosylated hemoglobin (HbA1c) level >10% or a glucose > 250 mg/dL at Screening

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • GI Associates & Endoscopy Center

    Jackson, Mississippi, 39202

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Northwest Gastroenterology Clinic

    Portland, Oregon, 97210

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Desert Sun Clinical Research

    Tucson, Arizona, 85710

  • Ventura Clinical Trials

    Ventura, California, 93003

Other trials in United States

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

This is a multicenter, randomized, double-blind, incomplete block, three period fixed sequence crossover, multicenter, placebo-controlled study. The study will assess three oral doses of velusetrag (5 mg, 15 mg, and/or 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in subjects with diabetic or idiopathic gastroparesis.

Study 0093 will evaluate the effect of velusetrag in subjects with diabetic or idiopathic gastroparesis by assessing changes in gastric emptying.

Conditions
Gastroparesis
Being tested
velusetrag dose 1, velusetrag dose 2, velusetrag dose 3, placebo
Keywords
Gastroparesis, Diabetic, Idiopathic, Delayed gastric emptying
Medical subject headings
Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • velusetrag dose 1Drug

    Also called TD-5108

  • velusetrag dose 2Drug

    Also called TD-5108

  • velusetrag dose 3Drug

    Also called TD-5108

  • placeboDrug

Study groups in NCT01718938
Study groupRoleWhat they receive
Sequence 1Experimental3-way crossover of velusetrag or placebo
Receives: Drug: velusetrag dose 1; Drug: velusetrag dose 2; Drug: velusetrag dose 3; Drug: placebo
Sequence 2Experimental3-way crossover of velusetrag or placebo
Receives: Drug: velusetrag dose 1; Drug: velusetrag dose 2; Drug: velusetrag dose 3; Drug: placebo
Sequence 3Experimental3-way crossover of velusetrag or placebo
Receives: Drug: velusetrag dose 1; Drug: velusetrag dose 2; Drug: velusetrag dose 3; Drug: placebo
Sequence 4Experimental3-way crossover of velusetrag or placebo
Receives: Drug: velusetrag dose 1; Drug: velusetrag dose 2; Drug: velusetrag dose 3; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastric emptying half time (GE t1/2)

    Measured: From baseline to week 5

Secondary outcomes (4)

  1. Duration of lag time to gastric emptying (tlag)

    Measured: From baseline to Week 5

  2. Vital signs

    Assess the safety and tolerability in subjects with diabetic or idiopathic gastroparesis

    Measured: From baseline to Day 49

  3. ECGs

    Measured: From baseline to Day 49

  4. Number of adverse events

    Measured: From baseline to Day 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2013
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01718938
Sponsor's protocol ID
0093
Status last verified
Feb 2018
First submitted
29 Oct 2012
Last updated
26 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • Kuo B, Barnes CN, Nguyen DD, Shaywitz D, Grimaldi M, Renzulli C, Canafax D, Parkman HP. Velusetrag accelerates gastric emptying in subjects with gastroparesis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 study. Aliment Pharmacol Ther. 2021 May;53(10):1090-1097. doi: 10.1111/apt.16344. Epub 2021 Apr 3.

    PubMed 33811761

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing velusetrag dose 1, velusetrag dose 2 and velusetrag dose 3 in people with Gastroparesis, run by Theravance Biopharma at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric emptying half time (GE t1/2) (time frame: From baseline to week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01718938, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.

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