EUCTR2017-000657-39-PT
Active, not recruiting
Phase 1
Randomised, double-blind, placebo-controlled, parallel-group, multi-centre, phase III trial to investigate the efficacy, safety and tolerability of Naloxone HCl PR Tablets in patients with opioid induced constipation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Develco Pharma Schweiz AG
- Enrollment
- 563
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients \=18 years of age with opioid induced constipation.
- •2\. Long\-term WHO step III opioid therapy for at least 3 months prior to screening for treatment of chronic non\-cancer related pain.
- •3\. Receiving a stable maintenance regimen with one long\-acting oral or transdermal WHO step III opioid (except tapentadol) consisting of a total daily dose of \=40 mg ME for a minimum of 4 weeks prior to screening, with no anticipated change in opioid dose requirement over the proposed trial period.
- •4\. Symptoms of constipation with onset after the start of opioid medication for at least the last 4 weeks prior to screening, comprising:
- •ALL of the following:
- •\- \< 3 spontaneous bowel movements (SBMs) per week
- •\- loose stools are rarely present without the use of laxatives
- •TWO or more of the following:
- •\- straining during at least 25% of defecations
- •\- lumpy or hard stools in at least 25% of defecations
Exclusion Criteria
- •1\. History of cancer in the last 2 years except basal cell carcinoma and non\-metastatic squamous cell skin cancer. Patients with any malignancy in the past are eligible in case they have been continuously disease\-free for at least 2 years.
- •2\. Known or suspected reason for constipation other than OIC (e.g. idiopathic, neurological, endocrine, or metabolic).
- •3\. Known or suspected medical conditions that might be associated with diarrhoea, intermittent loose stools or constipation, such as faecal incontinence or irritable bowel syndrome (IBS). In case of documented suspicion of IBS or justified doubts of a long ago diagnosis, the Rome IV criteria must be applied).
- •4\. Any known or suspected gastrointestinal (GI) pathology that might increase the risk of perforation, such as chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis), acute diverticulitis or history of \> 1 episode of diverticulitis, intestinal obstruction or pseudo\-obstruction.
- •5\. Any form of acute temporary or permanent GI ostomy, such as ileostomy or colostomy.
- •6\. Renal impairment requiring any form of dialysis.
- •7\. Known or suspected moderate\-to\-severe hepatic impairment (serum total bilirubin \> 2 upper limit of normal (ULN) except in patients diagnosed with Gilbert’s syndrome, International Normalised Ratio (INR) \> 2 ULN (except in patients on therapeutic anti\-coagulation), serum albumin \< 2\.8 g/dL)
- •8\. Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the trial treatment or may jeopardise patient's safety, compliance or adherence to protocol requirements, such as significant psychiatric, cardiovascular, pulmonary, metabolic, endocrine or neurological disease.
- •9\. Any GI pathology or surgery or intractable vomiting likely to significantly influence drug absorption.
- •10\. Inability to swallow the trial medication whole (e.g. due to dysphagia).
Outcomes
Primary Outcomes
Not specified
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