Prevention of opioid-induced constipation in patients with advanced cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Oct 2022 → ongoing

Decision date (initial)

2024-10-28

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-509462-38-00

EudraCT number

2022-000408-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

In patients with advanced cancer, starting with opioids for pain:
To prove non-inferiority of magnesium hydroxide to macrogol/electrolytes in the
prevention of OIC, based on the percentage of patients without constipation (BFI-score
<30) after 14 days of treatment.

Secondary objectives 6

1. In patients with advanced cancer, starting with opioids for pain: To compare magnesium hydroxide with macrogol/electrolytes with regard to the Rome IV criteria after 14 days of treatment;
2. To compare magnesium hydroxide with macrogol/electrolytes with regard to quality of life (as measured with the EQ5D) after 14 days of treatment;
3. To compare magnesium hydroxide with macrogol/electrolytes with regard to side effects and patient satisfaction with laxative after 14 days of treatment;
4. To compare magnesium hydroxide with macrogol/electrolytes with regard to difference in pain score between laxative treatment after 14 days of treatment;
5. To compare magnesium hydroxide with macrogol/electrolytes with regard to comparative cost-effectiveness;
6. To predict non-responders by gender, age, BMI, site of cancer, site of metastases and use of medication.

Conditions and MedDRA coding

Patients with advanced cancer.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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);
2. Starting with slow release or transdermal opioids for pain;
3. Able to complete a Dutch questionnaire.

Exclusion criteria 5

1. A potential subject who meets any of the following criteria will be excluded from participation in this study: Patients with contra-indications for laxatives;
2. Maintenance treatment with laxatives during the last two weeks
3. Severely impaired renal function (serum creatinine >180 umol/l);
4. Diarrhea at the start of the study, defined as the passage of three or more loose or liquid stools per day (or more frequent passage than is normal for the individual).
5. Life expectancy < 1 month

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index, measured on day 14.

Secondary endpoints 7

1. Change of the Bowel Function Index Score between day 0 and day 14;
2. Quality of life;
3. Rome IV criteria for opioid-induced constipation as judged by professional care givers;
4. Cancer pain score;
5. Side effects of laxatives;
6. Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide;
7. Patient satisfaction with laxative.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

Kay Kistemaker

Public contact point

Organisation

Amsterdam UMC

Contact name

Kay Kistemaker

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications