Overview
Sponsor-declared trial summary
Low Anterior Resection Syndrome
To investigate if patients who experience unsatisfactory improvement of bowel function and QOL by the end of the RCT when treated with glycerol suppositories, will improve on these parameters when treated with TAI and vice versa.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 24 Jul 2019 → 13 Apr 2026
- Decision date (initial)
- 2025-01-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Qufora A/S
External identifiers
- EU CT number
- 2024-519492-25-01
- EudraCT number
- 2019-001913-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate if patients who experience unsatisfactory improvement of bowel function and QOL by the end of the RCT when treated with glycerol suppositories, will improve on these parameters when treated with TAI and vice versa.
Conditions and MedDRA coding
Low Anterior Resection Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10080023 | Low anterior resection syndrome | 100000004863 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519492-25-00 | Comparison of transanal irrigation and glycerol suppositories in treatment of Low Anterior Resection Syndrome | Region Midtjylland |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Patients electively treated for rectal cancer with a low anterior resection. 2. Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score >29 at evaluation). 3. At least 3 months after surgery (including reversal of a temporary loop-ileostomy). 4. Age 18 years 5. Ability to understand written and spoken language actual for the including site (due to questionnaire validity).
Exclusion criteria 1
- 1. Former use of TAI 2. Prior systematic use of rectal emptying aids 3. Anastomotic stenosis 4. History of anastomotic leakage 5. Current metastatic disease or local recurrence 6. Ongoing oncological treatment 7. Postoperative radiotherapy for rectal cancer 8. Previous or current cancer in other pelvic organs than the rectum 9. Underlying diarrhoeal disease 10. Inflammatory bowel disease 11. Dementia 12. Spinal cord injury, multiple sclerosis, Parkinson’s disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms. 13. Inability of patient to use TAI 14. Inability and unwillingness to give informed consent 15. Pregnancy or intention to become pregnant during the trial period
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint will be change of the main symptom score assessed by the Measure Yourself Medical Outcome Profile (MYMOP) score comparing the TAI group to the glycerol suppository group.
Secondary endpoints 1
- 1. Assessment of bowel function with the LARS Score (27) and the Memorial Sloan-Kettering Cancer Centre (MSKCC) Bowel Function Instrument (BFI) (28)). 2. Assessment of the faecal incontinence status with The St. Mark’s Incontinence Score (29). 3. Assessment of QOL and bowel function-related QOL with the EORTC QLQ-C30 and EORTC QLQ-CR29 (30,31). 4. Assessment of urinary function with The International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms (ICIQ-M/F-L
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1713933 · Product
- Active substance
- Glycerol
- Pharmaceutical form
- SUPPOSITORY
- Route of administration
- RECTAL USE
- Max daily dose
- 1.2 g gram(s)
- Max total dose
- 100.8 g gram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- A06AX01 — GLYCEROL
- Marketing authorisation
- 8100
- MA holder
- OBA-PHARMA APS
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Peter Christensen
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Peter Christensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 8, Code 9 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 114 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2019-07-24 | 2019-09-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | protocol | 1 |
| Recruitment arrangements (for publication) | REC | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation_kliniskprospektivt studie_25082022 | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation_RCT_25082022 | 1 |
| Subject information and informed consent form (for publication) | Samtykkeerklringkliniskprospektivtstudie | 1 |
| Subject information and informed consent form (for publication) | SamtykkeerklringRCT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume_Referencedokument | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-18 | Denmark | Acceptable 2024-12-23
|
2025-01-10 |