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Opioid-Induced ConstipationPhase 3NaxosNCT03687268

Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation

A Phase 3 study testing Naloxone HCl PR tablets in people with Opioid-Induced Constipation, run by Develco Pharma Schweiz AG at 104 sites in 9 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid-Induced Constipation
What is being tested?
Naloxone HCl PR tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,500 participants
Where
104 sitesin 9 countries
Study dates
31 Jul 2017to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients ≥18 years of age with opioid induced constipation.
  • Long-term WHO step III opioid therapy for at least 3 months prior to screening for treatment of chronic non-cancer related pain.
  • 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.
  • Symptoms of constipation with onset after the start of opioid medication for at least the last 4 weeks prior to screening,

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

104 sites in 9 countries.

Nils Burger, PhD contact

+41614255020

n.burger@develco.ch

Karin Schmid contact

+41614255020

k.schmid@develco.ch

104 sites in 9 countries

United Kingdom28 sites, 28 recruiting

  • Aberdeen

    Aberdeen

    Recruiting

  • Addlestone

    Addlestone

    Recruiting

  • Belfast

    Belfast

    Recruiting

  • Chesterfield

    Chesterfield

    Recruiting

  • Clevedon

    Clevedon

    Recruiting

  • Cockermouth

    Cockermouth

    Recruiting

  • Corby

    Corby

    Recruiting

  • Dunfermline

    Dunfermline

    Recruiting

  • Durham

    Durham

    Recruiting

  • Fowey

    Fowey

    Recruiting

  • Guildford

    Guildford

    Recruiting

  • Kenilworth

    Kenilworth

    Recruiting

  • Leicester

    Leicester

    Recruiting

  • Macclesfield

    Macclesfield

    Recruiting

  • Margate

    Margate

    Recruiting

  • Middlesborough

    Middlesbrough

    Recruiting

  • Middlesex

    Middlesex

    Recruiting

  • Newcastle-Upon-Tyne

    Newcastle upon Tyne

    Recruiting

  • Northwood

    Northwood

    Recruiting

  • Penzance

    Penzance

    Recruiting

  • Plymouth

    Plymouth

    Recruiting

  • Romford

    Romford

    Recruiting

  • Salford

    Salford

    Recruiting

  • Sidcup

    Sidcup

    Recruiting

  • Sunderland

    Sunderland

    Recruiting

  • Thornton-Cleveleys

    Thornton-Cleveleys

    Recruiting

  • Wellingborough

    Wellingborough

    Recruiting

  • Wokingham

    Wokingham

    Recruiting

Other trials in United Kingdom

Germany15 sites, 15 recruiting

  • Bad Honnef

    Bad Honnef

    Recruiting

  • Bad Pyrmont

    Bad Pyrmont

    Recruiting

  • Berlin

    Berlin

    Recruiting

  • Böhlen

    Böhlen

    Recruiting

  • Bonn

    Bonn

    Recruiting

  • Eichstätt

    Eichstätt

    Recruiting

  • Fellbach

    Fellbach

    Recruiting

  • Göppingen

    Göppingen

    Recruiting

  • Hamburg

    Hamburg

    Recruiting

  • Jahnsdorf

    Jahnsdorf

    Recruiting

  • Kevelaer

    Kevelaer

    Recruiting

  • Marburg

    Marburg

    Recruiting

  • Münster

    Münster

    Recruiting

  • Stadtroda

    Stadtroda

    Recruiting

  • Würzburg

    Würzburg

    Recruiting

Other trials in Germany

Poland13 sites, 13 recruiting

  • Bialystok

    Bialystok

    Recruiting

  • Bielsko-Biala

    Bielsko-Biala

    Recruiting

  • Bydgoszcz

    Bydgoszcz

    Recruiting

  • Gdansk

    Gdansk

    Recruiting

  • Katowice

    Katowice

    Recruiting

  • Krakow

    Krakow

    Recruiting

  • Lodz

    Lodz

    Recruiting

  • Ostrowiec Swietokrzyski

    Ostrowiec Świętokrzyski

    Recruiting

  • Rzeszow

    Rzeszów

    Recruiting

  • Tarnow

    Tarnów

    Recruiting

  • Tychy

    Tychy

    Recruiting

  • Warszawa

    Warsaw

    Recruiting

  • Wloclawek

    Włocławek

    Recruiting

Other trials in Poland

Czechia12 sites, 12 recruiting

  • České Budějovice

    České Budějovice

    Recruiting

  • Choceň

    Choceň

    Recruiting

  • Hradec Králové

    Hradec Králové

    Recruiting

  • Liberec

    Liberec

    Recruiting

  • Most

    Most

    Recruiting

  • Ostrava

    Ostrava

    Recruiting

  • Plzeň

    Pilsen

    Recruiting

  • Praha 10

    Prague

    Recruiting

  • Sokolov

    Sokolov

    Recruiting

  • Uherské Hradiště

    Uherské Hradiště

    Recruiting

  • Zlín

    Zlín

    Recruiting

  • Znojmo

    Znojmo

    Recruiting

Other trials in Czechia

Serbia9 sites, 9 recruiting

  • Belgrade

    Belgrade

    Recruiting

  • Sremska Kamenica

    Kamenitz

    Recruiting

  • Kragujevac

    Kragujevac

    Recruiting

  • Nis

    Niš

    Recruiting

  • Novi Sad

    Novi Sad

    Recruiting

  • Sombor

    Sombor

    Recruiting

  • Subotica

    Subotica

    Recruiting

  • Vrbas

    Vrbas

    Recruiting

  • Zrenjanin

    Zrenjanin

    Recruiting

Other trials in Serbia

Portugal8 sites, 8 recruiting

  • Amadora

    Amadora

    Recruiting

  • Aveiro

    Aveiro

    Recruiting

  • Braga

    Braga

    Recruiting

  • Covilhã

    Covilha

    Recruiting

  • Guimarães

    Guimarães

    Recruiting

  • Leiria

    Leiria

    Recruiting

  • Matosinhos

    Matosinhos Municipality

    Recruiting

  • Setúbal

    Setúbal

    Recruiting

Other trials in Portugal

Slovakia8 sites, 8 recruiting

  • Banská Bystrica

    Banská Bystrica

    Recruiting

  • Bojnice

    Bojnice

    Recruiting

  • Bratislava

    Bratislava

    Recruiting

  • Dolný Kubín

    Dolný Kubín

    Recruiting

  • Košice

    Košice

    Recruiting

  • Prešov

    Prešov

    Recruiting

  • Rimavská Sobota

    Rimavská Sobota

    Recruiting

  • Žilina

    Žilina

    Recruiting

Other trials in Slovakia

Spain7 sites, 7 recruiting

  • Barcelona

    Barcelona

    Recruiting

  • Granada

    Granada

    Recruiting

  • Madrid

    Madrid

    Recruiting

  • Manises

    Manises

    Recruiting

  • Palma

    Palma de Mallorca

    Recruiting

  • Santiago de Compostela

    Santiago de Compostela

    Recruiting

  • Torrejón de Ardoz

    Torrejón de Ardoz

    Recruiting

Other trials in Spain

Bulgaria4 sites, 4 recruiting

  • Plovdiv

    Plovdiv

    Recruiting

  • Sevlievo

    Sevlievo

    Recruiting

  • Sofia

    Sofia

    Recruiting

  • Veliko Tarnovo

    Veliko Tarnovo

    Recruiting

Other trials in Bulgaria

About this study

Official title: 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

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):

Being tested
Naloxone HCl PR tablets, Placebo Oral Tablet
Medical subject headings
Opioid-Induced Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naloxone HCl PR tabletsDrug

    oral administration

  • Placebo Oral TabletDrug

    Placebo

Study groups in NCT03687268
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo Oral Tablet
Naloxone 24 mgExperimentalNot described
Receives: Drug: Naloxone HCl PR tablets
Naloxone 48 mgExperimentalNot described
Receives: Drug: Naloxone HCl PR tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2018
  2. Study start31 Jul 2017
  3. Primary completionNov 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03687268
Sponsor's protocol ID
0217/DEV
Acronym
Naxos
Status last verified
Sep 2018
First submitted
26 Sep 2018
Last updated
28 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Naloxone HCl PR tablets in people with Opioid-Induced Constipation, run by Develco Pharma Schweiz AG at 104 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United Kingdom, Germany, Poland, Czechia, Serbia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nils Burger, PhD (+41614255020, n.burger@develco.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of overall CSBM Responders. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03687268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.

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