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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT00452335
Eligibility Criteria:
Inclusion Criteria:
* Less than 18 years of age
* Weight of at least 12 kg and capable of swallowing a capsule
* Able to refrain from use of medications known to treat or associated with constipation symptoms
* Stable fiber therapy or ADHD therapy if using such medications
* Patient/Caregiver able to complete daily diary
* Patient able to use recommended rectal and/or oral rescue medications if needed
Exclusion Criteria:
* Constipation is associated with some medical, anatomic, physical, organic, or other condition
* Hirschsprung's Disease or Nonretentive Fecal Incontinence
* Untreated fecal impactions or impactions requiring digital manipulation
* Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion
* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss
* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion
* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
* Sexually active males and females must utilize acceptable birth control methods
* Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT00452335
Study Brief:
Protocol Section:
NCT00452335