Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
Launched by SHIRE · May 4, 2010
Trial Information
Current as of June 23, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria to be assessed at screening:
- • 1. Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
- • 2. Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.
- • 3. Subject is suffering from OIC (i.e. secondary to chronic opioid use).
- • 4. Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.
- Main exclusion criteria to be assessed at screening:
- • 1. Constipation is thought to be drug-induced (except for opioids)
- • 2. Disallowed medication is being used
- • 3. Subject was on chronic therapy for chronic constipation prior to start of opioid therapy
- • 4. Subject is suffering from secondary causes of chronic constipation.
About Shire
Shire, a global biotechnology company, specializes in developing innovative therapies for rare diseases and complex conditions. With a strong commitment to improving the lives of patients, Shire focuses on areas such as hematology, immunology, neuroscience, and genetic disorders. The company is dedicated to advancing clinical research and delivering breakthrough treatments that address unmet medical needs. Through collaboration and a patient-centric approach, Shire strives to enhance health outcomes and empower individuals affected by challenging health conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, , Belgium
Patients applied
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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