Clinical study to investigate the efficacy, safety and tolerability of Naloxone in patients with opioid induced constipation.
- Conditions
- Opioid induced constipationMedDRA version: 20.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000016726Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2017-000657-39-PT
- Lead Sponsor
- Develco Pharma Schweiz AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 563
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
- sensation of incomplete evacuation for at least 25% of defecations
- sensation of anorectal obstruction/ blockade for at least 25% of defecations
- manual manoeuvres for at least 25% of defecations (e.g. digital evacuation, support of the pelvic floor)
5. Willingness to stop at V2 all laxatives, enemas, stool softeners, and any other medications used to treat constipation with the exception of laxative rescue medication (i.e., bisacodyl tablets) allowed per protocol.
6. Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of medication, correct and independent completion of subjective evaluations (e.g. electronic diary, eDiary), attending scheduled visits, completing telephone interviews, and compliant with all protocol requirements, as evidenced by providing signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1044
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 448
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).
11. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis.
12. Signs and symptoms that may be related to opioid withdrawal.
13. Use of prohibited medication or treatments as defined in the list of not allowed medication or treatments.
14. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice acceptable contraceptive measures. For men: Men unable or unwilling to practice acceptable contraceptive measures.
15. Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days
16. Previous treatment in a clinical trial with Naloxone HCl PR Tablets (except one re-screening in this trial).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method