Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Temporarily halted
Participants planned
70
Countries
1
Sites
1
Benign prostatic hyperplasia
To evaluate the effect of tryptophan supplementation on lower urinary tract symptoms as assessed by the International Prostate Symptom Score (IPSS) on patients with known benign prostatic hyperplasia.
Key facts
- Sponsor
- CCAB Centro Clinico Academico Braga Associacao
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 5 Dec 2024 → ongoing
- Decision date (initial)
- 2024-11-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Centro Clínico Académico – Braga, Associação
External identifiers
- EU CT number
- 2024-519076-75-00
- EudraCT number
- 2021-000946-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the effect of tryptophan supplementation on lower urinary tract symptoms as assessed by the International Prostate Symptom Score (IPSS) on patients with known benign prostatic hyperplasia.
Secondary objectives 1
- To evaluate the effect of tryptophan supplementation on secondary endpoints, including changes in urine maximum flow rate (Qmax), prostate volume, assessed by trans-rectal ultra-sound, and erectile function, assessed by International Index of Erectile Function-5 (IIEF-5) and in quality of life due to urinary symptoms (question 8 of the IPSS).
Conditions and MedDRA coding
Benign prostatic hyperplasia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10004446 | Benign prostatic hyperplasia | 100000004872 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Written informed consent must be obtained before any assessment is performed
- Male patients with benign prostatic hyperplasia for which tamsulosin is the therapeutic option per SoC
- Aged ≥50 and less than 75 years old
- With prostate volume ≥30 cm3 by TRUS
- Diagnosed with LUTS defined by a stable IPSS total score ≥13 points
Exclusion criteria 14
- Patients with postvoid bladder residual volume ≥250 ml
- Patients with intravesical obstruction from any cause other than benign prostatic hyperplasia
- History of any procedure considered an intervention for benign prostatic hyperplasia
- Patients with active urinary tract infection
- History of recurrent urinary tract infections
- Current prostatitis or diagnosis of chronic prostatitis
- History of prostate or invasive bladder cancer
- Use of 5 α-reductase inhibitors within 6 months
- Phytotherapy within 2 weeks before entry
- Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors
- Patients with acute or chronic kidney failure
- Patients with diagnosed or suspicion of intolerance to lactose
- Patients submitted to general anesthesia in the past 4 weeks
- Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in the total score (questions 1–7) of the IPSS questionnaire
Secondary endpoints 1
- Urine maximum flow rate (Qmax); Erectile function, assessed by International Index of Erectile Function-5 (IIEF-5); and prostate volume (in cc), assessed by trans-rectal ultra-sound; and in quality of life due to urinary symptoms (question 8 of the IPSS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD619132 · Product
- Active substance
- Oxitriptan
- Substance synonyms
- 5-HYDROXYTRYPTOPHAN, 2-AMINO-3-(5-HYDROXY-1H-INDOL-3-YL)PROPANOIC ACID, 5-HTP
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- N06AX01 — OXITRIPTAN
- Marketing authorisation
- 8533315
- MA holder
- ANGELINI PHARMA PORTUGAL UNIPESSOAL LDA.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Omnic 0,4 mg, comprimidos de libertação prolongada, revestidos por película
PRD331733 · Product
- Active substance
- Tamsulosin Hydrochloride
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 0.4 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G04CA02 — TAMSULOSIN
- Marketing authorisation
- 5502489
- MA holder
- ASTELLAS FARMA LDA.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CCAB Centro Clinico Academico Braga Associacao
- Sponsor organisation
- CCAB Centro Clinico Academico Braga Associacao
- Address
- Lugar De Sete Fontes S Victor
- City
- Braga
- Postcode
- 4710-243
- Country
- Portugal
Scientific contact point
- Organisation
- CCAB Centro Clinico Academico Braga Associacao
- Contact name
- Clinical Project Manager
Public contact point
- Organisation
- CCAB Centro Clinico Academico Braga Associacao
- Contact name
- Executive director
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Temporarily halted | 70 | 1 |
| 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 |
|---|---|---|---|---|---|
| Portugal | 2024-12-05 | 2024-12-20 | 2026-04-02 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-127448
- Halt date
- 2026-04-02
- Member states concerned
- Portugal
- Publication date
- 2026-04-02
- Reason
- Feasibility (recruitment issues etc.)
- Explanation
- The study team is currently experiencing difficulties in recruiting participants in accordance with the initially approved conditions. It is anticipated that an expansion of participant identification and/ or recruitment to Family Health Units within ULSB will be necessary.
- Follow-up measures
- Three participants have been screened, but only two have received treatment. Both participants have completed their participation in the trial. As this temporary halt is not related to safety concerns, no additional measures are considered necessary.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2021-000946-16 | 2.0 |
| Protocol (for publication) | D1_Protocol_2021-000946-16 TC | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_IIEF-5 | NA |
| Protocol (for publication) | D4_Patient facing documents_IPSS | NA |
| Protocol (for publication) | Summary of Changes | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TC | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _IIEF-5 | Na |
| Subject information and informed consent form (for publication) | L2_Other subject information material _IPSS | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material IPSS TC | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cincofarm | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Omnic | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PT | 1.3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-18 | Portugal | Acceptable 2024-10-31
|
2024-11-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-29 | Portugal | Acceptable 2025-02-13
|
2025-02-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-28 | Portugal | Acceptable | 2025-04-30 |