GastroparesisPhase 2DIGESTNCT02267525
The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study
A Phase 2 study testing Velusetrag in people with Gastroparesis, run by Theravance Biopharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Velusetrag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jun 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis
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.
- Conditions
- Gastroparesis
- Being tested
- Velusetrag, Placebo
- Keywords
- Gastroparesis, Diabetic, Idiopathic
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelusetragDrug
Also called TD-5108
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Velusetrag 5mg | Experimental | Velusetrag 5mg capsules QD (once daily) x 12 weeks Receives: Drug: Velusetrag |
| Velusetrag 15mg | Experimental | Velusetrag 15mg capsules QD x 12 weeks Receives: Drug: Velusetrag |
| Velusetrag 30mg | Experimental | Velusetrag 30mg capsules QD x 12 weeks Receives: Drug: Velusetrag |
| Placebo | Placebo comparator | Placebo capsules QD x 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score
Measured: At Week 4
Secondary outcomes (2)
Gastric emptying half-time
Measured: At Week 4
Adverse events
Measured: 103 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alfasigma S.p.A.
- Responsible party
- Sponsor
- Investigators
- Deanna Nguyen, MD, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267525
- Sponsor's protocol ID
- 0099
- Acronym
- DIGEST
- Status last verified
- Apr 2018
- First submitted
- 14 Oct 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36624727
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis
- ClinicalTrials.gov ID
- NCT02267525
- Acronym / sponsor ID
- DIGEST / 0099
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Diabetic, Idiopathic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- Alfasigma S.p.A.
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Velusetrag 5mg | Experimental | Drug: VelusetragVelusetrag 5mg capsules QD (once daily) x 12 weeks |
| Velusetrag 15mg | Experimental | Drug: VelusetragVelusetrag 15mg capsules QD x 12 weeks |
| Velusetrag 30mg | Experimental | Drug: VelusetragVelusetrag 30mg capsules QD x 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules QD x 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VelusetragAlso: TD-5108 | Drug | Velusetrag 15mg, Velusetrag 30mg, Velusetrag 5mg |
| Placebo | Drug | Placebo |
Primary outcome
7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score
Time frame: At Week 4
2 secondary outcomes
Gastric emptying half-time
Time frame: At Week 4
Adverse events
Time frame: 103 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 36624727Abell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna Nguyen, MD study director
Theravance Biopharma
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velusetrag in people with Gastroparesis, run by Theravance Biopharma.
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 6 inclusion and 4 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
7-day mean GCSI-24H (Gastroparesis Cardinal Symptoms Index) composite score (time frame: At Week 4). 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 NCT02267525, 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 17 Apr 2018.