Single-dose Linaclotide for Capsule Endoscopy Preparation

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02465385
• Date of registration: 27/05/2015
• Prospective Registration: No
• Primary sponsor: University of Virginia
• Public title: Single-dose Linaclotide for Capsule Endoscopy Preparation
• Scientific title: Single-dose Linaclotide for Capsule Endoscopy Preparation
• Date of first enrolment: February 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02465385
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Rachel Hays, MD
• Affiliation: Assistant professor

Key inclusion & exclusion criteria

Inclusion Criteria:

- Schedule for video endoscopy at UVHS

- Ability to speak, read and write English

- Age >18

- Able to provide consent

Exclusion Criteria:

- Prisoner

- Woman who is currently pregnant or breastfeeding

- Allergy to linaclotide

- Patients with known or suspected mechanical gastrointestinal obstruction



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's

Ulcerative Colitis

Gastrointestinal Bleeding

Intervention(s)

Drug: Linaclotide

Primary Outcome(s)

Small bowel transit time [Time Frame: 10 hours post-dose]

Secondary Outcome(s)

Overall mucosal visualization on the recorded images as rated by an expert reviewer and graded on a 5-point likert scale. [Time Frame: 10 hours post-dose]

Secondary ID(s)

17803

Source(s) of Monetary Support

Please refer to primary and secondary sponsors