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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03687268
Other study ID # 0217/DEV
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 31, 2017
Est. completion date December 2019

Study information

Verified date September 2018
Source Develco Pharma Schweiz AG
Contact Nils Burger, PhD
Phone +41614255020
Email n.burger@develco.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily.

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):


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date December 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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,

Exclusion Criteria:

- 1. Hypersensitivity or intolerance to any active substance (i.e., naloxone, bisacodyl) or any of the excipients of the trial medication (e.g. patients with hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption). Hypersensitivity or intolerance to methylnaltrexone or naloxegol.

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naloxone HCl PR tablets
oral administration
Placebo Oral Tablet
Placebo

Locations

Country Name City State
Bulgaria Plovdiv Plovdiv
Bulgaria Sevlievo Sevlievo
Bulgaria Sofia Sofia
Bulgaria Veliko Tarnovo Veliko Tarnovo
Czechia Ceské Budejovice Ceské Budejovice
Czechia Chocen Chocen
Czechia Hradec Králové Hradec Králové
Czechia Liberec Liberec
Czechia Most Most
Czechia Ostrava Ostrava
Czechia Plzen Plzen
Czechia Praha 10 Praha 10
Czechia Sokolov Sokolov
Czechia Uherské Hradište Uherské Hradište
Czechia Zlín Zlín
Czechia Znojmo Znojmo
Germany Bad Honnef Bad Honnef
Germany Bad Pyrmont Bad Pyrmont
Germany Berlin Berlin
Germany Böhlen Böhlen
Germany Bonn Bonn
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
Poland Bialystok Bialystok
Poland Bielsko-Biala Bielsko-Biala
Poland Bydgoszcz Bydgoszcz
Poland Gdansk Gdansk
Poland Katowice Katowice
Poland Krakow Kraków
Poland Lodz Lódz
Poland Ostrowiec Swietokrzyski Ostrowiec Swietokrzyski
Poland Rzeszow Rzeszów
Poland Tarnow Tarnów
Poland Tychy Tychy
Poland Warszawa Warszawa
Poland Wloclawek Wloclawek
Portugal Amadora Amadora
Portugal Aveiro Aveiro
Portugal Braga Braga
Portugal Covilhã Covilhã
Portugal Guimarães Guimarães
Portugal Leiria Leiria
Portugal Matosinhos Matosinhos
Portugal Setúbal Setúbal
Serbia Belgrade Belgrade
Serbia Kragujevac Kragujevac
Serbia Nis Niš
Serbia Novi Sad Novi Sad
Serbia Sombor Sombor
Serbia Sremska Kamenica Sremska Kamenica
Serbia Subotica Subotica
Serbia Vrbas Vrbas
Serbia Zrenjanin Zrenjanin
Slovakia Žilina Žilina
Slovakia 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
Spain 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
United Kingdom 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

Sponsors (1)

Lead Sponsor Collaborator
Develco Pharma Schweiz AG

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Germany,  Poland,  Portugal,  Serbia,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of overall CSBM Responders. Overall CSBM response defined as = 3 CSBMs/week and an increase of = 1 CSBM/week compared to baseline during at least 9 out of the 12 treatment weeks, including all of the last 4 weeks. 12 weeks
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