Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
10
Pharmakogenetics
To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions.
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 5 Oct 2022 → ongoing
- Decision date (initial)
- 2022-05-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Dose response
To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions.
Secondary objectives 4
- 1. To evaluate whether treatment adjusted according to CYP2D6 phenotype can reduce adverse reactions to tramadol in acute postoperative pain.
- 2. To compare the efficacy and safety of dexketoprofen and tramadol in the treatment of acute postoperative pain.
- 3. To investigate the influence on analgesic response and the incidence of adverse reactions of polymorphisms of other genes involved in the pharmacokinetics and mechanism of action of dexketoprofen and tramadol, such as: CYP2C9, CYP2C8, CYP2C19, CYP3A4, CYP3A5, CYP2B6, CYP2E1, COMT, ABCB1, SLC22A1, OPRM1 and PTGS2.
- 4. To evaluate the relationship of tramadol, M1 and dexketoprofen plasma concentrations with response to treatment and the occurrence of adverse reactions.
Conditions and MedDRA coding
Pharmakogenetics
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Los datos no se compartiran con ningún otro centro. Se respetara la ley de protección de datos como se especifiica en el de declaración responsable de cumpliemnto con esta ley.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500377-13-00 | Randomized clinical trial to evaluate the utility of CYP2D6 genotyping to improve the efficacy and safety of tramadol in the treatment of acute postoperative pain | Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 1. Men or women over 18 years of age.
- 2. Patients scheduled for outpatient surgical extraction, under local anesthesia, of at least two impacted third molars, at least one of which will require bone removal.
- 3. Patients who agree to participate in the study and give written consent.
Exclusion criteria 6
- 1. Patients under treatment with other drugs that can inhibit CYP2D6, or are contraindicated in combination with tramadol or dexketoprofen.
- 2. Patients on treatment with bisphosphonates.
- 3. Patients who are receiving analgesic treatment before the operation, 24 hours prior to the operation. This criterion will be evaluated at the intervention visit.
- 4. Patients suffering from other uncontrolled diseases.
- 5. Pregnant or breastfeeding women.
- 6. Patients with contraindications for treatment with tramadol or dexketoprofen.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Dexketoprofeno Normon 25 mg comprimidos recubiertos con película EFG
PRD910146 · Product
- Active substance
- Dexketoprofen Trometamol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 225 mg milligram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- M01AE17 — DEXKETOPROFEN
- Marketing authorisation
- 77751
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tramadol Normon 50 mg cápsulas duras EFG
PRD909624 · Product
- Active substance
- Tramadol Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 450 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AX02 — TRAMADOL
- Marketing authorisation
- 63910
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Tramadol Normon 100 mg cápsulas duras
PRD8948199 · Product
- Active substance
- Tramadol Hydrochloride
- Substance synonyms
- TRAMADOL HCL, (±)-TRANS-2-DIMETHYLAMINOMETHYL-1-(3-METHOXYPHENYL)CYCLOHEXANOL HYDROCHLORIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AX02 — TRAMADOL
- Marketing authorisation
- 85977
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Metamizol Normon 575 mg cápsulas duras EFG.
PRD400114 · Product
- Active substance
- Metamizole Magnesium
- Substance synonyms
- DIPYRONE MAGNESIUM, DIPYRONE MAGNESIUM SALT
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 2300 mg milligram(s)
- Max total dose
- 6900 g gram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BB02 — METAMIZOLE SODIUM
- Marketing authorisation
- 63431
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paracetamol Normon 500 mg comprimidos EFG
PRD404208 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 6 g gram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 68330
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Address
- Calle De Diego De Leon 62
- City
- Madrid
- Postcode
- 28006
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Contact name
- Fundacion Para La Investigacion Biomedica
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Contact name
- Fundacion Para La Investigacion Biomedica
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 300 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital General Universitario De Alicante
Maxilofacial, ª Centro De Diagnosticos, Avinguda Del Pintor Baeza 12, Alicante
University Hospital Ramón Y Cajal
Maxilofacial, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario De La Princesa
Maxilofacial, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Fundación Jiménez Díaz
Maxilofacial, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic San Carlos
Maxilofacial, C Doctor Martín Lagos, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Maxilofacial, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Area De Salud De Burgos Y Soria
Maxilofacial, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Universitario La Paz
Cirugía Maxilofacial, Paseo Castellana 261, 28046, Madrid
Hospital Central De La Defensa Gomez Ulla
Servicio de cirugía oral y maxilofacial, Glorieta Del Ejercito S/N, 28047, Madrid
Hospital Universitario 12 De Octubre
Servicio de cirugía oral y maxilofacial, Avenida De Cordoba Sn, 28041, Madrid
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 |
|---|---|---|---|---|---|
| Spain | 2022-10-05 | 2022-10-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo_V1_020222 | 3 |
| Recruitment arrangements - Extract (for publication) | Tradol PriMe-Historia Guiada_v2_171022 | 1 |
| Recruitment arrangements (for publication) | MR2_Twitter_JNR_200223_signed | 1 |
| Recruitment arrangements (for publication) | Reclutamiento_Pacientes_Version1_2022_03_18 | 1 |
| Subject information and informed consent form - Extract (for publication) | Receta_V1_171022_para el paciente | 1 |
| Subject information and informed consent form (for publication) | HIP_general_Tradol-PriME_V1_2022_02_28 | 1 |
| Subject information and informed consent form (for publication) | HIP_Tradol_V3_171022_final | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_DexketoprofenoNormon25mgComprimidosRecubiertosConPeliculaEFG | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_TramadolNormon100mgCapsulasDuras | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_TramadolNormon50mgCapsulasDurasEFG | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-04-18 | Spain | Acceptable 2022-05-27
|
2022-05-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-10-31 | Spain | Acceptable | 2022-11-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-02-21 | Spain | Acceptable | 2023-02-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-07 | Spain | Acceptable 2025-03-31
|
2025-03-31 |