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Prevention study for Constipation, Opioid-Induced
Official title Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT05216328
What this study is testing
What is Macrogol Only Product in Oral Dose Form?
Macrogol Only Product in Oral Dose Form is an investigational medicine, given as an once-daily, being studied as a potential treatment for constipation, opioid-induced.
Also referred to as Macrogol/electrolytes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients with metastatic 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.
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients with contra-indications for laxatives
- Use of laxatives during the last four weeks
- Severely impaired renal function (serum creatinine \>180 umol/l)
- Estimated life expectancy \<3 months
The study team makes the final eligibility decision.
Where it's taking place
- Almere Stad, Flevoland, Netherlands
- Arnhem, Gelderland, Netherlands
- Nijmegen, Gelderland, Netherlands
- 's-Hertogenbosch, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Hoofddorp, North Holland, Netherlands
- Gouda, South Holland, Netherlands
- Leiden, South Holland, Netherlands
- Rotterdam, South Holland, Netherlands
- The Hague, South Holland, Netherlands
- Groningen, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Almere Stad, Flevoland, Netherlands; Arnhem, Gelderland, Netherlands; Nijmegen, Gelderland, Netherlands; 's-Hertogenbosch, North Brabant, Netherlands; Amsterdam, North Holland, Netherlands; Hoofddorp, North Holland, Netherlands and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.