Diabetic GastroparesisPhase 2NCT03281577
Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants
A Phase 2 study testing TAK-954 in people with Diabetic Gastroparesis and Idiopathic Gastroparesis, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Gastroparesis, Idiopathic Gastroparesis
- What is being tested?
- TAK-954
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 12 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has diabetes mellitus with symptoms of gastroparesis and previously documented gastric emptying delay or previously documented idiopathic gastroparesis in the last 5 years.
- Has a body mass index (BMI) greater than or equal to (>=) 16 and less than or equal to (<=) 40 kilogram per square meter (kg/m^2) at the Screening Visit.
Who cannot join
- Has glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%).
- Has other structural diseases/conditions that affect the gastrointestinal (GI) system.
- Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.
- Has clinically significant abnormal baseline safety laboratory values.
- Has preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
- Are without known preexisting hepatic disease who have 1 or more of the following:
Show all 15Show fewer
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal (ULN).
- Bilirubin >1.5 times the ULN unless due to Gilbert's syndrome.
- International normalized ratio (INR) >1.5 unless on anticoagulation therapy.
- Has QT intervals with Fridericia correction method (QTcF) interval (>=) 460 millisecond (msec) or with other factors that increase the risk of QT prolongation or arrhythmic events at screening. Note: Participants with bundle branch block and a prolonged QTc interval, or with QTcF between 450 and 460 msec, should be reviewed by the Medical Monitor for potential inclusion.
- Has second or third degree atrioventricular (AV) block; AV disassociation; >5 beats of non-sustained VT at a rate >120 beats per minute (bpm); Electrocardiogram (ECG) changes consistent with acute myocardial ischemia or infarction.
- Has cardiac history that includes conditions requiring heart rate control (example, atrial fibrillation, atrial flutter, ventricular tachycardia, or other tachyarrhythmias).
- Has clinical evidence (including physical examination, ECG, clinical laboratory value and review of the medical history) of significant cardiovascular, respiratory, moderate or severe renal insufficiency (creatinine clearance <=60 mL/min), hematological, neurological, or psychiatric disease, or other disease that interferes with the objectives of the study.
- If female, are pregnant or lactating or intending to become pregnant before participating in this study, during the study, and 4 to 5 days (5 half-lives) PLUS 30 days after last dose of the study drug; or intending to donate ova during such time period.
- Are considered by the investigator to be alcoholics not in remission or known substance abusers. Have a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 milliliter per [mL/] 12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-Ranging, Randomized, Parallel, Placebo-Controlled Study to Assess the Effect of TAK-954 on Gastrointestinal and Colonic Transit in Patients With Diabetic or Idiopathic Gastroparesis
The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.
Read the detailed description
The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4) receptor agonist and is being tested to treat people who have diabetic or idiopathic gastroparesis and who previously reported delay in stomach emptying. This study will look at the gastric emptying time of solids in people who take TAK-954 or placebo.
The study will enroll approximately 41 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-954 0.1 mg
- TAK-954 0.3 mg
- TAK-954 1 mg
- Placebo (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient.
This single center trial will be conducted in the United States. The duration of treatment is 3 days and the overall period of evaluation is up to 28 days. The participants will be contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another follow-up phone call for women of childbearing potential (Days 38 to 43).
- Conditions
- Diabetic Gastroparesis, Idiopathic Gastroparesis
- Being tested
- TAK-954, Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-954Drug
TAK-954 IV infusion.
PlaceboDrug
TAK-954 placebo-matching IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3. Receives: Drug: Placebo |
| TAK-954 0.1 mg | Experimental | TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. Receives: Drug: TAK-954 |
| TAK-954 0.3 mg | Experimental | TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days. Receives: Drug: TAK-954 |
| TAK-954 1 mg | Experimental | TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. Receives: Drug: TAK-954 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids
Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
Measured: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2
Secondary outcomes (6)
Colonic Geometric Center
The scintigraphic method was used to measure colonic geometric center following a radio-labelled meal. The geometric center (GC) was the weighted average of counts in the different colonic regions, where 0= no radioactivity in the colon and if radioactivity was detected in the colon, 1=all isotope was in the ascending colon and 5=all isotope was in the stool; a high GC indicated faster colonic transit.
Measured: 4, 24, and 48 hours post-radiolabeled meal on Day 2
Colonic Filling at Hour 6
Colonic filling was estimated as percentage of the radio-labelled meal that reached the colon at Hour 6.
Measured: 6 hours post-radiolabel meal on Day 2
Half-emptying Time (T1/2) of Ascending Colon
T1/2 of ascending colon emptying was estimated by analysis of proportionate emptying over time of counts from the colon. Scintigraphy assessments were used to evaluate the emptying of solids or liquids from ascending colon following a radio-labelled meal.
Measured: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
Measured: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Cmax: Maximum Observed Plasma Concentration for TAK-954
Measured: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Ctrough: Observed Plasma Concentration at the End of a Dosing Interval
Measured: At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start2 Jan 2018
- Primary completion7 Jun 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281577
- Sponsor's protocol ID
- TAK-954-2003
- Other IDs
- U1111-1200-9396
- Status last verified
- Dec 2020
- First submitted
- 11 Sep 2017
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Chedid V, Brandler J, Arndt K, Vijayvargiya P, Wang XJ, Burton D, Harmsen WS, Siegelman J, Chen C, Chen Y, Almansa C, Dukes G, Camilleri M. Randomised study: effects of the 5-HT4 receptor agonist felcisetrag vs placebo on gut transit in patients with gastroparesis. Aliment Pharmacol Ther. 2021 May;53(9):1010-1020. doi: 10.1111/apt.16304. Epub 2021 Mar 12.
PubMed 33711180
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging, Randomized, Parallel, Placebo-Controlled Study to Assess the Effect of TAK-954 on Gastrointestinal and Colonic Transit in Patients With Diabetic or Idiopathic Gastroparesis
- ClinicalTrials.gov ID
- NCT03281577
- Acronym / sponsor ID
- TAK-954-2003
- Conditions
- Diabetic Gastroparesis, Idiopathic Gastroparesis
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Posted 15 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.
Detailed description
The drug being tested in this study is called TAK-954. TAK-954 is a serotonin (5 HT4) receptor agonist and is being tested to treat people who have diabetic or idiopathic gastroparesis and who previously reported delay in stomach emptying. This study will look at the gastric emptying time of solids in people who take TAK-954 or placebo.
The study will enroll approximately 41 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-954 0.1 mg
- TAK-954 0.3 mg
- TAK-954 1 mg
- Placebo (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient.
This single center trial will be conducted in the United States. The duration of treatment is 3 days and the overall period of evaluation is up to 28 days. The participants will be contacted by telephone (Days 10 to 14) for follow-up assessment. There will be another follow-up phone call for women of childbearing potential (Days 38 to 43).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once daily on Days 1 to 3. |
| TAK-954 0.1 mg | Experimental | Drug: TAK-954TAK-954 0.1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
| TAK-954 0.3 mg | Experimental | Drug: TAK-954TAK-954 1 mg, 60-minute infusion, IV, once daily for up to 3 days. |
| TAK-954 1 mg | Experimental | Drug: TAK-954TAK-954 1 mg, 60-minute infusion, IV, once daily on Days 1 to 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has diabetes mellitus with symptoms of gastroparesis and previously documented gastric emptying delay or previously documented idiopathic gastroparesis in the last 5 years.
- Has a body mass index (BMI) greater than or equal to (>=) 16 and less than or equal to (<=) 40 kilogram per square meter (kg/m^2) at the Screening Visit.
Key exclusion criteria (15 listed)
- Has glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%).
- Has other structural diseases/conditions that affect the gastrointestinal (GI) system.
- Are unable to withdraw drugs known to alter GI transit 48 hours prior to the study.
- Has clinically significant abnormal baseline safety laboratory values.
- Has preexisting hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
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 |
|---|---|---|
| TAK-954TAK-954 IV infusion. | Drug | TAK-954 0.1 mg, TAK-954 0.3 mg, TAK-954 1 mg |
| PlaceboTAK-954 placebo-matching IV infusion. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids
Time frame: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2
Half-emptying time (t1/2) of gastric solids is the time for half of the ingested solids or liquids to leave the stomach. Scintigraphy assessments were used to evaluate the gastric emptying of solids following a radio-labelled meal. A negative percent change from baseline indicated improvement.
6 secondary outcomes
Colonic Geometric Center
Time frame: 4, 24, and 48 hours post-radiolabeled meal on Day 2
Colonic Filling at Hour 6
Time frame: 6 hours post-radiolabel meal on Day 2
Half-emptying Time (T1/2) of Ascending Colon
Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
AUCtau: Area Under the Plasma Concentration-Time Curve From Time 0 to t for TAK-954
Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Cmax: Maximum Observed Plasma Concentration for TAK-954
Time frame: Predose and at multiple time-points post-dose (up to 25 hours) on Days 1, 2 and 3
Ctrough: Observed Plasma Concentration at the End of a Dosing Interval
Time frame: At multiple time-points post-dose, up to 9 hours on Day 2 and up to 25 hours on Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33711180Chedid V, Brandler J, Arndt K, Vijayvargiya P, Wang XJ, Burton D, Harmsen WS, Siegelman J, Chen C, Chen Y, Almansa C, Dukes G, Camilleri M. Randomised study: effects of the 5-HT4 receptor agonist felcisetrag vs placebo on gut transit in patients with gastroparesis. Aliment Pharmacol Ther. 2021 May;53(9):1010-1020. doi: 10.1111/apt.16304. Epub 2021 Mar 12.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-954 in people with Diabetic Gastroparesis and Idiopathic Gastroparesis, run by Takeda at 1 site 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 2 inclusion and 15 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Half-emptying Time (T1/2) of Gastric Solids (time frame: Predose and at multiple time-points post-dose (up to 9 hours) on Day 2). 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 NCT03281577, 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 7 Jan 2021.