Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
NCT ID: NCT03687268
Last Updated: 2018-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1500 participants
INTERVENTIONAL
2017-07-31
2019-12-31
Brief Summary
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The trial will consist of four phases:
Screening phase (Week -4 to Week -3):
Confirmation phase (Week -2 to Week -1):
Double-blind treatment phase
Follow-up phase (Week 13-14):
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo Oral Tablet
Placebo
Naloxone 24 mg
Naloxone HCl PR tablets
oral administration
Naloxone 48 mg
Naloxone HCl PR tablets
oral administration
Interventions
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Naloxone HCl PR tablets
oral administration
Placebo Oral Tablet
Placebo
Eligibility Criteria
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Inclusion Criteria
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,
Exclusion Criteria
2\. 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.
3\. Known or suspected reason for constipation other than OIC (e.g. idiopathic, neurological, endocrine, or metabolic).
4\. 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).
5\. 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.
6\. Any form of acute temporary or permanent GI ostomy, such as ileostomy or colostomy.
7\. Renal impairment requiring any form of dialysis. 8. 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) 9. 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.
10\. Any GI pathology or surgery or intractable vomiting likely to significantly influence drug absorption.
11\. Inability to swallow the trial medication whole (e.g. due to dysphagia). 12. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis.
13\. Signs and symptoms that may be related to opioid withdrawal. 14. Use of prohibited medication or treatments as defined in the list of not allowed medication or treatments.
15\. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice acceptable contraceptive measures. Acceptable methods for women are hormonal contraceptives, surgical intervention (e.g. bilateral tubal occlusion), intrauterine device, intrauterine hormone-releasing system, double-barrier methods and true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. For men: Men unable or unwilling to practice acceptable contraceptive measures. Acceptable methods for men are surgical intervention (e.g. vasectomy), true sexual abstinence and acceptable contraception (as described above) of the female partner.
16\. Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days (or five half-lives of IMP whichever is longer) prior to Visit 1 (except one re-screening in this trial).
17\. Previous treatment in a clinical trial with Naloxone HCl PR Tablets (except one re-screening in this trial).
18\. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
19\. Employees of the investigator or trial centre, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial centre, as well as family members of the employees or the investigator.
18 Years
ALL
No
Sponsors
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Develco Pharma Schweiz AG
INDUSTRY
Responsible Party
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Locations
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Plovdiv
Plovdiv, , Bulgaria
Sevlievo
Sevlievo, , Bulgaria
Sofia
Sofia, , Bulgaria
Veliko Tarnovo
Veliko Tarnovo, , Bulgaria
Choceň
Choceň, , Czechia
České Budějovice
České Budějovice, , Czechia
Hradec Králové
Hradec Králové, , Czechia
Liberec
Liberec, , Czechia
Most
Most, , Czechia
Ostrava
Ostrava, , Czechia
Plzeň
Pilsen, , Czechia
Praha 10
Prague, , Czechia
Sokolov
Sokolov, , Czechia
Uherské Hradiště
Uherské Hradiště, , Czechia
Zlín
Zlín, , Czechia
Znojmo
Znojmo, , Czechia
Bad Honnef
Bad Honnef, , Germany
Bad Pyrmont
Bad Pyrmont, , Germany
Berlin
Berlin, , Germany
Bonn
Bonn, , Germany
Böhlen
Böhlen, , Germany
Eichstätt
Eichstätt, , Germany
Fellbach
Fellbach, , Germany
Göppingen
Göppingen, , Germany
Hamburg
Hamburg, , Germany
Jahnsdorf
Jahnsdorf, , Germany
Kevelaer
Kevelaer, , Germany
Marburg
Marburg, , Germany
Münster
Münster, , Germany
Stadtroda
Stadtroda, , Germany
Würzburg
Würzburg, , Germany
Bialystok
Bialystok, , Poland
Bielsko-Biala
Bielsko-Biala, , Poland
Bydgoszcz
Bydgoszcz, , Poland
Gdansk
Gdansk, , Poland
Katowice
Katowice, , Poland
Krakow
Krakow, , Poland
Lodz
Lodz, , Poland
Ostrowiec Swietokrzyski
Ostrowiec Świętokrzyski, , Poland
Rzeszow
Rzeszów, , Poland
Tarnow
Tarnów, , Poland
Tychy
Tychy, , Poland
Warszawa
Warsaw, , Poland
Wloclawek
Włocławek, , Poland
Amadora
Amadora, , Portugal
Aveiro
Aveiro, , Portugal
Braga
Braga, , Portugal
Covilhã
Covilha, , Portugal
Guimarães
Guimarães, , Portugal
Leiria
Leiria, , Portugal
Matosinhos
Matosinhos Municipality, , Portugal
Setúbal
Setúbal, , Portugal
Belgrade
Belgrade, , Serbia
Sremska Kamenica
Kamenitz, , Serbia
Kragujevac
Kragujevac, , Serbia
Nis
Niš, , Serbia
Novi Sad
Novi Sad, , Serbia
Sombor
Sombor, , Serbia
Subotica
Subotica, , Serbia
Vrbas
Vrbas, , Serbia
Zrenjanin
Zrenjanin, , Serbia
Banská Bystrica
Banská Bystrica, , Slovakia
Bojnice
Bojnice, , Slovakia
Bratislava
Bratislava, , Slovakia
Dolný Kubín
Dolný Kubín, , Slovakia
Košice
Košice, , Slovakia
Prešov
Prešov, , Slovakia
Rimavská Sobota
Rimavská Sobota, , Slovakia
Žilina
Žilina, , Slovakia
Barcelona
Barcelona, , Spain
Granada
Granada, , Spain
Madrid
Madrid, , Spain
Manises
Manises, , Spain
Palma
Palma de Mallorca, , Spain
Santiago de Compostela
Santiago de Compostela, , Spain
Torrejón de Ardoz
Torrejón de Ardoz, , Spain
Aberdeen
Aberdeen, , United Kingdom
Addlestone
Addlestone, , United Kingdom
Belfast
Belfast, , United Kingdom
Chesterfield
Chesterfield, , United Kingdom
Clevedon
Clevedon, , United Kingdom
Cockermouth
Cockermouth, , United Kingdom
Corby
Corby, , United Kingdom
Dunfermline
Dunfermline, , United Kingdom
Durham
Durham, , United Kingdom
Fowey
Fowey, , United Kingdom
Guildford
Guildford, , United Kingdom
Kenilworth
Kenilworth, , United Kingdom
Leicester
Leicester, , United Kingdom
Macclesfield
Macclesfield, , United Kingdom
Margate
Margate, , United Kingdom
Middlesborough
Middlesbrough, , United Kingdom
Middlesex
Middlesex, , United Kingdom
Newcastle-Upon-Tyne
Newcastle upon Tyne, , United Kingdom
Northwood
Northwood, , United Kingdom
Penzance
Penzance, , United Kingdom
Plymouth
Plymouth, , United Kingdom
Romford
Romford, , United Kingdom
Salford
Salford, , United Kingdom
Sidcup
Sidcup, , United Kingdom
Sunderland
Sunderland, , United Kingdom
Thornton-Cleveleys
Thornton-Cleveleys, , United Kingdom
Wellingborough
Wellingborough, , United Kingdom
Wokingham
Wokingham, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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0217/DEV
Identifier Type: -
Identifier Source: org_study_id