Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
110
Countries
1
Sites
3
Fibrotic Interstitial Lung Disease
The main object of the study is to examine the effect of 4 weeks treatment with slow-release morphine compared to placebo on the perception of breathlessness in patients with fibrotic interstitial lung diseases.
Key facts
- Sponsor
- Aarhus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 23 Aug 2024 → ongoing
- Decision date (initial)
- 2024-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Karen Elise Jensens Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The main object of the study is to examine the effect of 4 weeks treatment with slow-release morphine compared to placebo on the perception of breathlessness in patients with fibrotic interstitial lung diseases.
Secondary objectives 1
- To examine the effect of 4 weeks treatment with slow-release morphine on the perception of cough, physical exertion and quality of life in patients with fibrotic interstitial lung diseases.
Conditions and MedDRA coding
Fibrotic Interstitial Lung Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10022611 | Interstitial lung disease | 100000004855 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period Treatment with morphine or placebo for 4 weeks, plus increasing dosage and tapering after the trial.
|
Randomised Controlled | Double | [{"id":87088,"code":4,"name":"Analyst"},{"id":87086,"code":2,"name":"Investigator"},{"id":87090,"code":3,"name":"Monitor"},{"id":87089,"code":1,"name":"Subject"},{"id":87087,"code":5,"name":"Carer"}] | morphine: Group treated with morphine. Placebo: Group treated with placebo. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- fibrotic interstitial lung disease
- GAP (Gneder-Age-Physiology) score 2-3
- Presence of fibroses on HRCT (tractionbronchiectasis, honeycombing, loss of volume >10% assessed by the investigator
- MRC (Medical Research Councils) dyspnea score ≥ 3
- Informed written consent
- Age ≥ 18 år
- Authoritative
Exclusion criteria 5
- Regular treatment with morphine or morphine analogues
- Allergy or intolerance to morphine or morphine analogues
- Ongoing infection or exacerbation
- Patients with so severe impaired respiration that any form of worsening would be too risky (assessed by the investigator)
- Treatment with benzodiazepines (not benzodiazepine receptor agonists)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The change in average VAS score for dyspnea the last 24-hours (baseline) measured over a week and after 4 weeks treatment with morphine.
Secondary endpoints 4
- Change in walking distance during 6-minute walk test from baseline to follow-up after 4 weeks of treatment
- Change in level of desaturation at 6-minute walk test from baseline to follow-up after 4 weeks of treatment
- Change in BORG dyspnea scale at 6-minute walk test from baseline to follow-up after 4 weeks of treatment
- Change in questionnaire (VAS for tough, Leicester Cough Questionnaire, King's Brief Lung Disease Questionnaire, COPD assessment Score) from baseline to follow-up after 4 weeks of treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD632484 · Product
- Active substance
- Morphine Sulfate
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 17251
- MA holder
- TEVA B.V
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8880402 · Product
- Active substance
- Morphine Sulfate
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 10801
- MA holder
- MUNDIPHARMA A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8880395 · Product
- Active substance
- Morphine Sulfate
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 15421
- MA holder
- MUNDIPHARMA A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MST CONTINUS 5 mg prolonged-release tablets
PRD506613 · Product
- Active substance
- Morphine Sulfate
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- PA 1688/004/001
- MA holder
- MUNDIPHARMA PHARMACEUTICALS LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Sissel Kronborg-White
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Sissel Kronborg-White
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring, Code 9 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 110 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Gentofte Hospital
Department of Respiratory Diseases, Kildegårdsvej 28, 2900, Hellerup
Aarhus University Hospital
Department of Respiratory Diseases and Allergy, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Respiratory Diseases, J B Winsloews Vej 4, 5000, Odense C
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 | 2024-08-23 | 2024-08-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2023-503700-81-00 | 3 |
| Protocol (for publication) | D4 patient facing document CAT | 1 |
| Protocol (for publication) | D4 patient facing document cough VAS | 1 |
| Protocol (for publication) | D4 patient facing document Dyspnea VAS | 1 |
| Protocol (for publication) | D4 patient facing document K-BILD | 1 |
| Protocol (for publication) | D4 patient facing document Leicester Cough | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SPC Contalgin depottabletter 5 mg og 10 mg | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC contalgin 5 mg | 2 |
| Synopsis of the protocol (for publication) | D1 protocol Synopsis ENG 2023-503700-81-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-22 | Denmark | Acceptable 2024-02-28
|
2024-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-30 | Denmark | Acceptable 2024-10-24
|
2024-10-24 |