GastroparesisPhase 1/2NCT02187094
Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
A Phase 1/2 study testing TC-6499 in people with Gastroparesis, run by Targacept Inc. at 8 sites in United States.
Trial summary
Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- TC-6499
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2014to Jan 2015
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score >22)
- Gastroparesis confirmed using the GEBT
- Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%
- Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT
- Body Mass Index (BMI) ≤ 40
- Willingness to remain in clinical research facility for the protocol-required days of treatment and study procedures
- Willingness to use a double barrier method of birth control (except post-menopausal females)
- Able to understand study procedures and provide written informed consent
Who cannot join
- History of abdominal surgery including gastric banding procedure
- Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube
- Persistent daily vomiting
- A history of eating disorder
- Recent history of poor control of diabetes
- Acute severe gastroenteritis
Show all 14Show fewer
- Have implanted or use any type of gastric electric stimulator
- Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs
- Use of medications potentially influencing upper gastrointestinal motility or appetite
- Allergies or intolerance to egg, wheat, milk, or algae
- Pregnant or lactating females
- Presence of a clinically significant medical condition at any time during the study
- Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
- Participated in an investigational drug study within 30 days of screening
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
ClinSearch, LLC
Chattanooga, Tennessee, 37421
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Prefered Research Partners, Inc.
Little Rock, Arkansas, 72211
Horizon Research Group, Inc.
Mobile, Alabama, 36608
Quality Medical Research
Nashville, Tennessee, 37211
Aspen Clinical Research, LLC
Orem, Utah, 84058
Wake Research associates, LLC
Raleigh, North Carolina, 27612
Ventura Clinical Trials
Ventura, California, 93003
About this study
Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.
Read the detailed description
This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in diabetic subjects with gastroparesis. The length of study participation for a subject is up to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period, subjects will complete 4 overnight drug assessment visits (treatment arms) where they will receive a randomized single dose of study drug and the GEBT. Each overnight visit will be separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4 dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).
- Conditions
- Gastroparesis
- Being tested
- TC-6499, Placebo
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-6499Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One capsule of placebo administered as a single dose. Receives: Drug: Placebo |
| 2 mg TC-6499 | Experimental | One capsule of 2 mg TC-6499 administered as a single dose. Receives: Drug: TC-6499 |
| 5 mg TC-6499 | Experimental | One capsule of 5 mg TC-6499 administered as a single dose. Receives: Drug: TC-6499 |
| 10 mg TC-6499 | Experimental | One capsule of 10 mg TC-6499 administered as a single dose. Receives: Drug: TC-6499 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
Gastric emptying time will be assessed using the oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT) administered following each treatment.
Measured: 4 hrs post-GEBT meal
Secondary outcomes (2)
The percent dose excreted as 13-CO2 at specific post-meal time points for each treatment relative to placebo after single dose administration of study drug in each arm.
Measured: 90 and 120 min post-GEBT meal
The time of maximal rate of 13-CO2 expiration for each treatment relative to placebo after single dose administration of study drug in each arm.
Measured: 4 hrs post-GEBT meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targacept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187094
- Sponsor's protocol ID
- TC-6499-12-CLP-005
- Status last verified
- May 2015
- First submitted
- 30 Jun 2014
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
- ClinicalTrials.gov ID
- NCT02187094
- Acronym / sponsor ID
- TC-6499-12-CLP-005
- Conditions
- Gastroparesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Targacept Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jul 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.
Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.
Detailed description
This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in diabetic subjects with gastroparesis. The length of study participation for a subject is up to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period, subjects will complete 4 overnight drug assessment visits (treatment arms) where they will receive a randomized single dose of study drug and the GEBT. Each overnight visit will be separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4 dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOne capsule of placebo administered as a single dose. |
| 2 mg TC-6499 | Experimental | Drug: TC-6499One capsule of 2 mg TC-6499 administered as a single dose. |
| 5 mg TC-6499 | Experimental | Drug: TC-6499One capsule of 5 mg TC-6499 administered as a single dose. |
| 10 mg TC-6499 | Experimental | Drug: TC-6499One capsule of 10 mg TC-6499 administered as a single dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score >22)
- Gastroparesis confirmed using the GEBT
- Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%
- Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT
- Body Mass Index (BMI) ≤ 40
Key exclusion criteria (14 listed)
- History of abdominal surgery including gastric banding procedure
- Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube
- Persistent daily vomiting
- A history of eating disorder
- Recent history of poor control of diabetes
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 |
|---|---|---|
| TC-6499 | Drug | 10 mg TC-6499, 2 mg TC-6499, 5 mg TC-6499 |
| Placebo | Drug | Placebo |
Primary outcome
The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
Time frame: 4 hrs post-GEBT meal
Gastric emptying time will be assessed using the oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT) administered following each treatment.
2 secondary outcomes
The percent dose excreted as 13-CO2 at specific post-meal time points for each treatment relative to placebo after single dose administration of study drug in each arm.
Time frame: 90 and 120 min post-GEBT meal
The time of maximal rate of 13-CO2 expiration for each treatment relative to placebo after single dose administration of study drug in each arm.
Time frame: 4 hrs post-GEBT meal
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 12 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TC-6499 in people with Gastroparesis, run by Targacept Inc. at 8 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 8 inclusion and 14 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm. (time frame: 4 hrs post-GEBT meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2015.