Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03012594
Eligibility Criteria:
Inclusion Criteria:
1. Consecutive patients with evidence of small bowel motility disorders, referred to (or) are patients of the Gastroenterology and Motility Center at Northwell Health System.
2. Aged between 18 and 70 years.
3. Subjects should be capable of understanding the study and be able to give informed consent.
4. Patient having small bowel motility disorder as evidenced by delayed small bowel transit by wireless motility capsule (WMC) testing to \> 6 hours.
5. To participate in the study, patients will have to stop taking Octreotide (because it has the same mechanism of action as the study medication) if they are currently taking it; it should be stopped for at least 4 weeks before taking the first dose of this study medication.
General Exclusion Criteria
1. Age \<18 or age \>70
2. Pregnancy as assessed by urine pregnancy test.
Exclusion Criteria for performing wireless motility capsule testing
1. History of gastric bezoar
2. History of Disorders of swallowing
3. Known or suspected small bowel diverticula, diverticulitis, strictures, fistulas, Crohn's disease, or any other relevant medical comorbidity (e.g. chronic alcohol abuse)
4. Prior intestinal surgery, including Ileocecal(IC) valve resection or gastrointestinal surgeries that create a blind loop (e.g. Bilroth II or Roux-en-Y)
5. History of Severe dysphagia to food or pills
6. A participant who uses an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
7. Inability to be off intestinal transit altering medication for at least one week (e.g. opiates, laxatives, etc.)
8. Any person unable or unwilling to undergo abdominal surgery.
9. BMI \> 40.
Exclusion Criteria due to Lanreotide
1. Current use or recent (within last 7 days) use of acid suppressive therapy, prokinetic agents, laxatives, and opiates, or other agents known to affect gastrointestinal motility.
2. Disorders associated with presumed small intestinal motility disorders including: scleroderma, intestinal pseudo-obstruction, and autonomic visceral neuropathy (e.g. longstanding diabetes of more than 20 years and/or poorly controlled diabetes (glucose \> 250, glycosylated hemoglobin (HbA1c) \> 8.5%)
3. Current use of cyclosporine (Gengraf, Neoral, or Sandimmune), a medicine called bromocriptine (Parlodel, Cycloset), or medicines that lower heart rate, such as beta blockers.
4. Cardiac arrhythmia based on health history (palpitations, feeling a pause between heartbeats, lightheadedness, passing out, shortness of breath, or chest pain).
Bradycardia and Tachycardia are monitored during every visit to the clinic, using pulse rate.
ECG will be performed during screening visit and during 8th week of the study. The following are accessed with ECG.
* Bradycardia \<60 beats/min.
* Tachycardia \>100 beats/min.
* Atrial Fibrillation - Rapid irregular atrial signal with no real P-waves and irregular ventricular rate.
* Ventricular Fibrillation - Irregular ventricular waveforms.
* Sinus Arrhythmia - Normal beats, but triggered at an irregular interval from 60 to 100 beats per minute, causing varying R-R interval.
* Missed beats.
5. Chronic kidney disease (moderate and severe renal impairment as calculated by creatinine clearance of \<50 mL/min)
6. Hepatic Impairment - Subjects with Child-Pugh Class B and Class C.
7. Significant electrolyte abnormalities: Anything outside of the normal range by +/- 20 % will be considered as abnormal.
8. Cholelithiasis (Total bilirubin \>2x of normal)
9. Pancreatitis
10. Hepatitis (Aspartate transaminase (AST), Alanine transaminase (ALT) or Alkaline phosphatase (Alk Ph), greater than upper limit of normal(ULN), Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range)
11. Present cholecystitis
12. Uncontrolled congestive heart failure
13. Known hypersensitivity to the study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03012594
Study Brief:
Protocol Section:
NCT03012594