Do you have diabetic gastroparesis?
If so, consider joining envision 3D study, a diabetic gastroparesis clinical trial investigating a potential delayed gastric emptying treatment.
What is the envision 3D study?
envision 3D is researching CIN-102, a study medication called CIN-102 (deudomperidone). The envision 3D study is for people who have gastroparesis and diabetes type 1 or 2.
Who can join the envision 3D study?
You may be able to join the study if you meet the following requirements:
- Age 18 or older
- Diagnosed with Type 1 or Type 2 diabetes
- Diagnosed with gastroparesis, including gastrointestinal symptoms such as:
- Nausea or vomiting after eating
- feeling too full after eating
- bloating
- throat or stomach pain within the last 6 months
- documented delayed gastric emptying within the last 2 years.
What will happen during the study?
For participants: This tool is to help you understand what to expect during the envision 3D study.
- Read and sign the Informed Consent Form (ICF) before you receive any study assessments.
- Confirm study requirements – Visit the study clinic 2 times over < 5 weeks for study assessments to confirm if you qualify for the study. This is called Screening.
- Be assigned to a study group – Be assigned at random to receive either the study medication (CIN-102) or a placebo (no active ingredients).
- Take study capsules for 12 weeks – Take 2 capsules of the study medication or placebo twice per day for 12 weeks.
- Attend study clinic visits – Visit the study clinic 4 times over 12 weeks for study health assessments.
- Complete study follow-up – Visit the study clinic 1 more time for final health assessments, 1 week after your last dose.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
About the Study Medication
You may qualify for a diabetic gastroparesis clinical trial researching a new potential medication.
What is the study medication?
The study medication, called CIN-102 or deudomperidone, is a new form of domperidone. Domperidone is used in many countries outside of the United States for symptoms of diabetic gastroparesis. Unfortunately, domperidone can have serious side effects, so it is not approved for use in the United States but can be used under a special agreement between a physician and the Food and Drug Administration.
Deudomperidone is made by slightly changing domperidone. It is expected to have similar benefits with fewer side effects. However, more research is needed.
Will I receive the study medication?
Participants will be assigned at random (like the flip of a coin) to receive either the study medication (CIN-102) or placebo (no active ingredients)
What is an “investigational medicine?”
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the envision 3D study.
About Diabetic Gastroparesis
You may qualify for the envision 3D study investigating deudomperidone for diabetic gastroparesis. Learn more about diabetes and delayed gastric emptying.
What is diabetic gastroparesis?
Diabetic gastroparesis is a condition that causes the stomach to not empty normally. It occurs in people with type 1 or 2 diabetes who experience damage to the vagus nerve. The vagus nerve helps your stomach muscles move food through the stomach and into the digestive tract. Once the vagus nerve is damaged, it can cause stomach discomfort, severe nausea, or vomiting after eating. These symptoms can be hard to manage and lead to other complications.
Although a medication (domperidone) to treat diabetic gastroparesis is used in many countries, it is not approved in the United States because it has been associated with serious side effects. It can be used under a special agreement between a physician and the Food and Drug Administration. The study medication (deudomperidone) is expected to have similar benefits with fewer side effects. What we learn from the envision 3D study may help researchers learn more about a potential new option for people with diabetic gastroparesis.
Other common terms for gastroparesis are:
- Delayed gastric emptying
- Slow stomach emptying
- Lazy stomach
- Gastropathy
Where can I learn more?
https://www.mayoclinic.org/gastroparesis-causes
TRIUMpH Study
Are you struggling to manage acid reflux symptoms?
If so, consider joining the TRIUMpH study, a clinical trial for people with erosive esophagitis (EE) investigating a new potential treatment. Study participation helps impact the progression of erosive esophagitis (EE) research.
What is the TRIUMpH study?
The TRIUMpH clinical research study is researching a study medication for people with non-erosive reflux disease (NERD). The purpose of this study is to measure the safety and effectiveness of the study medication in people with NERD.
Who can join the TRIUMpH study?
Study participants may be able to join the study if they meet the following requirements:
- 18 years of age or older
- Experiencing heartburn and/or regurgitation consistent with non-erosive reflux disease (NERD)
- Able to undergo an upper GI endoscopy
Other study requirements will apply
What will happen during the study?
Participation in the TRIUMpH study lasts about 28 weeks total. Study participants can expect the following:
- Review & sign the Informed Consent Form.
- Screening (up to 2 weeks): Receive study health assessments to confirm if you qualify for the study. You will receive an endoscopy during screening, unless you have previously received an endoscopy that qualifies you for the study.
- Study Treatment period part 1 (4 weeks): You will be randomly assigned to take either the study medication or a placebo.
Placebo looks like the study medication, but it does not have any active ingredients. Neither you nor the study doctor will know your assignment. - Study Treatment period part 2 (20 weeks): All participants receive the study medication (no placebo) and continue visiting the study clinic regularly for assessments.
- Follow-up period (2 weeks after last dose): You will complete 1 follow-up visit at the study clinic. During this visit, you will receive study health assessments.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
About the Study Medication
What is the study medication?
The study medication is designed to block the production of stomach acid, reducing EE symptoms. Both the study medication and an FDA-approved PPI (standard of care medication) are taken by mouth.
Will I receive the study drug?
For both parts of this study, you will be randomly assigned (like the flip of a coin) to receive either the study medication or an FDA-approved PPI (standard of care medication). The study staff will also supply TUMS to help relieve your EE symptoms if needed.
What is an “investigational medicine?”
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like TRIUMpH.
About Erosive Esophagitis
What is erosive esophagitis (EE)?
Erosive esophagitis is an extreme form of acid reflux. It occurs when stomach acid flows backward into the esophagus, causing pain and irritation. People with EE can also have damage to the esophagus.
The main symptoms of EE are a burning sensation in the chest (heartburn) and uncomfortable movement of material from the stomach through the esophagus (regurgitation).
Some people do not respond to the current treatments available for EE. The TRIUMpH research study is researching a study medication to potentially provide another option for people with EE.
The FLAIR Study – Now Enrolling
The FLAIR Study is evaluating the effectiveness and safety of a combination of 2 commercially approved drugs, fluticasone (Fp) and albuterol (ABS), in a single inhaler compared to albuterol (ABS) alone for asthma attacks in adults, adolescents, and children with asthma.
The study will determine if using the study combination will reduce the occurrence of asthma episodes (“attacks”) that require systemic corticosteroids or hospitalizations for treatment.
Important Study Information
- During the study, participants will continue taking their usual asthma maintenance medication
- Participants will be in the study for at least 6 months
- The investigational study drug and study procedures are provided at no charge
- Travel and study-related costs may be reimbursed
- There is no placebo arm in this study; participants will receive either the study drug combination or ABS
- The study enrollment is expected to last until approximately the third quarter of 2025
Who can participate in the FLAIR Study?
To participate in this study, you must:
- Be 18 years of age or older
- Be diagnosed with asthma for at least 1 year
- Have had 1 or more severe asthma attacks in the past 12 months
There are also other requirements that will determine who can participate. A doctor will determine if you are medically eligible to take part in this study.
The Enviva Study – Now Enrolling
Are you living with Irritable Bowel Syndrome with Persistent Diarrhea (IBS-D)?
If so, consider joining the Enviva study, an IBS clinical trial for people with IBS-D investigating a new potential irritable bowel syndrome treatment.
What is the Enviva study?
Enviva is a Phase 2 clinical research study.
The goal of Enviva is to explore the effect of an investigational drug on the symptoms of irritable bowel syndrome with predominant diarrhea (IBS-D).
Researchers are studying how the investigational drug may help ease unpleasant symptoms, such as abdominal pain, bloating, and altered stool consistency.
Who can join the Enviva Study?
Study participants may be able to join the study if they meet the following requirements:
- 18 years of age or older
- Confirmed diagnosis of IBS-D
- Have no expected changes to their lifestyle, exercise routine, and/or diet during study participation
- Are willing to complete a daily diary of symptoms through a mobile app
Other study requirements will apply
What will happen during the study?
Participation in the Enviva study lasts about lasts about 19 weeks. Study participants can expect the following:
Review & Sign the Informed Consent Form | The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests and procedures. |
Screening Period (Up to 3 Weeks) | Complete assessments to determine if you meet the
requirements to participate in the study. Use of anti-diarrheal medication is allowed. |
Baseline Period (2 Weeks) | Receive instructions for completing the daily eDiary to record your symptoms of abdominal pain and bloating, as well as your stool consistency, frequency, and urgency.
Stop use of any anti-diarrheal medications, including medication used during the Screening Period. |
Dosing Period (12 Weeks) | Take your assigned dose twice daily, continue to complete the daily eDiary, and visit the study clinic 5 times for study assessments.
Use of anti-diarrheal medications should be limited and discussed with the study doctor. |
Follow-up Period (Up to 2 Weeks) | Talk to a member of the study team after your final dose. This visit may happen over the phone or at the study clinic. |
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
About the Investigational Drug
What is the investigational drug?
The investigational drug, CIN-103, is a new formulation of a gastrointestinal drug called phloroglucinol. Phloroglucinol is used outside of the United States to relieve painful spasms within the GI tract. The investigational drug is designed to work similarly to help relieve symptoms of pain, cramping, and diarrhea by treating the painful spasms that occur in the GI tract.
Will I receive the study drug?
Participants are randomly assigned to a dose that may include either the investigational drug, a matching placebo, or a combination of the two.
What is an “investigational drug?”
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like Enviva.
About Irritable Bowel Syndrome with Predominant Diarrhea (IBS-D)
What is IBS-D?
Irritable Bowel Syndrome is a collection of symptoms that appear together without the presence of damage or disease to the digestive tract. Individuals with IBS experience abdominal pain and changes to their bowel movements that include diarrhea, constipation, or both.
It is estimated that about 12% of the US population suffers from IBS. Factors that increase the likelihood of developing IBS include a family history of IBS, a history of stressful life events, and severe infection of the digestive tract.
The subtype of IBS known as Irritable Bowel Syndrome with Persistent Diarrhea (IBS-D) is defined by abnormal bowel movement where more than a quarter of stools are loose and watery.
Current therapy options include prescription medications, stress management, and dietary supplements. Enviva is researching an investigational drug that works differently than currently approved medications and has potential to help relieve unpleasant symptoms.
Overview of Clinical Trials
Here are some common questions and answers about study participation.
What are clinical research studies (trials)?
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
What is informed consent?
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
What does study participation involve?
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
See If You Qualify
To see if you might qualify for the study, please fill out the interest form below or give us a call at (336) 883-9773.