Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2022-000408-36-NL
EUCTR2022-000408-36-NL
Active, not recruiting
Phase 1

OMAMA-study – prevention of opioid-induced constipation in patients with advanced cancer - OMAMA-study

ZonMw0 sites330 target enrollmentStarted: September 11, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsOpioid-induced constipation in patients with advanced cancer, starting with opioids for painMedDRA version: 24.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Cancer [C04]
DrugsMOVICOLON Naturel 13,7 g, poeder voor drankMagnesiumhydroxide Teva 724 mg, kauwtabletten

Overview

Phase
Phase 1
Status
Active, not recruiting
Sponsor
ZonMw
Enrollment
330
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • •Patients with advanced cancer (\=18 years);
  • •Starting with slow release or transdermal opioids for pain;
  • •Able to complete a Dutch questionnaire.
  • •Previous treatment with opioids is allowed, if discontinued more than 4 weeks ago
  • •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 110
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • •Patients with contra\-indications for laxatives
  • •Maintenance treatment with laxatives during the last two weeks
  • •Severely impaired renal function (serum creatinine \>180 umol/l)
  • •Estimated life expectancy \<1 month

Investigators

Sponsor
ZonMw

Similar Trials

Recruiting
Phase 4
*Prevention of opioid-induced constipation in patients with advanced cancer*constipation10018012
NL-OMON53756Amsterdam UMC330
Recruiting
Not Applicable
Observational study on opioid-induced constipation in patients with non-cancer chronic pain using weak opioid analgesics in JapaOpioid Induced Constipation
JPRN-UMIN000050203Shionogi &amp; Co., Ltd.60
Not yet recruiting
Phase 4
Prevention of opioid-associated constipation in ventilated intensive care patientsConstipationOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonAnaesthesiology - Pain management
ACTRN12620000207910Dr Eamon Raith300
Completed
Phase 2
Naloxone SR Capsules in Patients With Opioid Induced ConstipationChronic PainOpioid Induced Constipation
NCT00984334S.L.A. Pharma AG40
Active, not recruiting
Not Applicable
Prevention of constipation during treatment with opioids: magnesiumoxide versus macrogol/elektrolytes
EUCTR2007-007610-10-NLMC Utrecht