Trials Sponsors Conditions Drugs Pricing

Conditions

Moderate to severe somatic pain.

Outcome Measures

Primary Outcomes (1)

Sum of the Pain Intensity Differences from the start of administration until after 12 hours (SPID0-12h), measured through the Visual Analogue Scale (VAS).

Secondary Outcomes (11)

Pain intensity (PI) and pain intensity difference (PID) in scheduled assessment times up to 48 hours from the start of administration of the study medication.
Area Under the Curve of pain intensity differences during the first 12 hours of study medication administration.
Sum of the pain intensity differences regarding baseline, at 6 hours (SPID0-6h) from the start of the administration of the study medication.
Patient responder rate, defined as the percentage of patients with a SPID(0-12h) ≥ δs
Time to first pain relief (Pain intensity ↓33%).
+6 more secondary outcomes

Interventions

Espididol 400 mg granulado para solución oral sabor mentaType not reported

Adolonta 100 mg/ml solución oralType not reported

PL 1 Granules for oral solutionType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Espididol 400 mg granulado para solución oral sabor menta
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry record
Formulated product
Adolonta 100 mg/ml solución oral
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL DROPS, SOLUTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Espididol 400 mg granulado para solución oral sabor menta
Named ingredient: ibuprofen arginine
View registry record
Adolonta 100 mg/ml solución oral
Named ingredient: Tramadol hydrochloride
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures
Patients ≥ 18 years at screening visit.
With a body mass index ≥ 18.5 and < 35 kg / m2 at the screening visit (BMI = weight/height2 = kg/m2).

Sponsors & Collaborators

Farmalider S.A.
Industrylead

Study Sites (9)

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Julio Acero Sanz+34913368000 j-acero@telefonica.net

Hospital Del Mar

Barcelona, 08003, Spain

Ana María Aldea Perona+34932483039 aaldea@researchmar.net

Hospital Universitario Reina Sofia

Cordoba, 14004, Spain

Alicia Dean Ferrer+34957010380

Central Study Contacts

Carlos Calandria

+34916612335 carloscalandria@farmalider.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

October 16, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-517807-35-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:46:32 UTC

Documents

D1_Protocol 2024-517807-35-00

You may not qualify if:

Patients with a history of allergy or hypersensitivity to study medication, rescue medication, acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID) or opioid, or any of their excipients.
History of asthma, bronchospasm, urticaria or angioneurotic oedema.
Active peptic ulcer, gastrointestinal disorders due to NSAIDs, active gastrointestinal bleeding or history of gastrointestinal bleeding.
Haemorrhagic diathesis or other coagulation disorders.
Current renal or hepatic insufficiency; or a recent history of moderate or severe impairment of renal, hepatic or cardiac function.
Epilepsy.
Crohn's disease or ulcerative colitis.
Patients who for other reasons should not receive treatment with NSAIDs or tramadol.
Patients who, apart from the anaesthetic procedure, cannot abstain from alcohol, psychotropic drugs or sedatives (e.g. benzodiazepines) 72 hours before the start of surgery until 48 hours after the end of the study treatment.
History of drug dependency: alcohol, opiates, hypnotics, amphetamines, cocaine, hallucinogens, cannabis or synthetic drugs.
Patients who have consumed analgesics, muscle relaxants or anti-inflammatories (including prescription and over-the-counter drugs) 24 hours prior to the start of surgery, or 5 days prior in the case of consumption of COX-2 inhibitors, up to 48 hours after the end of the study medication.
Patients in treatment with any other medicinal product that should not be administered due to the risk of adverse interactions with the study medication or interference with the assessments: listed in protocol section 10.2.2 Prohibited medication.
Patients who have suffered complications during surgery, a duration of surgery of more than 1 hour or who have required re-anaesthesia (after reaching the appropriate level of anaesthesia).
Unresolved infection on the day of surgery if the surgery is severe or requires treatment with systemic antibiotic therapy.
Any other disease, relevant laboratory abnormality or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study (e.g., patients with acute pain of different origin or location at the time of surgery).
+2 more criteria

Randomised, double-blind, placebo-controlled, active-treatment clinical trial to assess the analgesic efficacy and safety of an oral combination of ibuprofen (arginine) -tramadol HCl administered to patients with moderate to severe pain after undergoing dental surgery.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations