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:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT02063659
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years of age
* All patients of reproductive potential must agree to use an adequate method of contraception during the study and for 12 weeks after the Follow-up visit.
* Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor
* Documented history of carcinoid syndrome
* Patient is able and willing to provide written informed consent prior to participation
Exclusion Criteria:
* Presence of diarrhea attributed to any condition other than carcinoid syndrome.
* Presence of 12 or more watery bowel movements per day
* Positive stool examination for enteric pathogens, pathogenic ova or parasites, of Clostridium difficile at Screening
* Karnofsky Performance Status ≤ 60%
* Presence of any clinically significant laboratory, medical history, or physical examination findings deemed unacceptable by the Investigator
* A history of short bowel syndrome
* History of constipation within 2 years of Screening
* Life expectancy \< 12 months from Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02063659
Study Brief:
Protocol Section:
NCT02063659