Naldemedine OIBD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aalborg University Hospital

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

12 Aug 2024 → ongoing

Decision date (initial)

2023-12-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Shionogi & Co., LTD. + Mech-Sense, Aalborg University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main obejctive is to investigate the effect of naldemedine on opioid (tramadol) induced bowel dysfunction, using an objective design to explore gastrointestinal transit, motility pattern, secretion and colonic volume.

Conditions and MedDRA coding

Opioid induced bowel dysfunction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. • Healthy (assessed by a study-affiliated medical doctor)
2. • Signed informed consent
3. • Able to read and understand Danish
4. • Male or female
5. • Northern European descent (to minimize genetic variance influences on drug metabolism)
6. • The researcher believes that the participant understands the study details, is compliant and is expected to complete the study
7. • Opioid naïve
8. • Between 20 and 60 years of age
9. • A STAI score in the range of 20-37 i.e., classified as “no or low anxiety” at inclusion
10. • Negative pregnancy test at screening and before each treatment visit (female participants only)
11. • Agreed to use highly effective contraception during the entire study (female participants only)

Exclusion criteria 15

1. • Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study
2. • Daily alcohol consumption
3. • Participation motivated by “wrongful” reasons such as poor economy or psychosocial issues e.g., problems in the family, loneliness, sadness. People with such problems may be more likely to develop substance dependence
4. • Intake of alcohol within 48 hours before start of study period or any alcohol consumption during each study period. If consumption takes place during the study the participant will be excluded
5. • Use of any analgesic medication within 48 hours before start as well as for the duration of the study
6. • Nicotine use
7. • Less than three spontaneous bowel movements per week
8. • Participation in other studies within 14 days prior to first visit
9. • Expected need of medical/surgical treatment during the study
10. • Any diagnosed disease, which investigator concludes will affect the trial (including all contraindicated complications: severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, paralytic ileus, hypercapnia, serious respiratory depression with hypoxia, moderate to severe decreased liver function, gastrointestinal obstruction or perforation, acute surgical abdominal complications such as appendicitis, Mb. Crohn’s, ulcerative colitis, and toxic mega colon)
11. • History of substance abuse (alcohol, THC, benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start)
12. • History of major mental disorders (e.g., major anxiety, major depression or treatment with psychoactive medications etc.)
13. • Metal implants or pacemaker
14. • Daily use of prescription only medicine
15. • Lactating

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. • Total GI transit time (MTS-2)
2. • Colorectal transit time (MTS-2)

Secondary endpoints 8

1. • Subjective assessments of constipation (PAC-SYM, BSFS, GSRS, BFI)
2. • Diagnostic evaluation of opioid-induced constipation (Rome IV C6)
3. • Subjective assessment of opiate withdrawal (SOWS)
4. • Segmental transit time of the stomach, small intestine, and colonic segments (assessed with MTS-2)
5. • Detailed colonic motility (assessed with 3D-Transit)
6. • Colon volume (assessed with MRI)
7. • Water content in the colon (assessed with MRI)
8. • Rear-front pressures and defecation indices (measured by Fecobionics)

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aalborg University Hospital

Sponsor organisation

Aalborg University Hospital

Address

Moelleparkvej 4

City

Aalborg

Postcode

9000

Country

Denmark

Scientific contact point

Organisation

Aalborg University Hospital

Contact name

Asbjørn Mohr Drewes

Public contact point

Organisation

Aalborg University Hospital

Contact name

Asbjørn Mohr Drewes

Third parties 1

Locations

1 EU/EEA country · 1 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

Temporary halts 1 · Art. 38 CTR

Results and documents

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

Documents 15 files

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

Application history

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