Clinical trial to evaluate the clinical effect and safety of a triple combination of ibuprofen, magnesium and vitamin C in the treatment of acute pain in temporomandibular disorders (TMD).

• Conditions: Temporomandibular joint dysfunction syndrome.; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2014-003790-41-ES
• Lead Sponsor: Spherium Biomed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Patients previously diagnosed or in the screening of TMD who are in acute phase of articular +/- muscle pain (either relapse or onset of pain symptoms), with or without restriction of mouth opening (whether they are carriers of joint stabilization splint or not) (groups the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD) Ia: myofascial pain, Ib: myofascial pain with limited opening +/- IIIa: arthralgia and / or IIIb: osteoarthritis of the temporomandibular joint (TMJ)).
2) Severity of pain at diagnosis ? 4 VAS assessed by a scale of 10 cm.
3) Patients aged between 18 and 65 years.
4) Body mass index (BMI) within the normal range (19 to 30 kg / m2).
5) Patients who present an ASA physical status I or II (according to the classification of the American Society of Anesthesiologists - ASA).
6) Patients who have not participated during the three months prior to this study in a previous clinical trial.
7) Patients who voluntarily participate in the study and sign the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1) Patients who plan to become pregnant, are pregnant and / or lactating, or not wishing to use effective contraception (hormonal contraceptives [implementation, patches, oral], and double-barrier methods [any double combination of : IUD, male or female condoms with spermicidal jelly, diaphragm, contraceptive sponge, cervical cap]).
2) Patients with hypersensitivity or allergy to the investigational product (PEI), or to chemically related products or placebo.
3)Alcohol or drug dependence history (including history of consumption of psychotropic substances) within 3 months prior to the inclusion visit.
4) Patients with a high consumption of stimulating beverages (> 5 coffee, tea or cola a day).
5) Patients who present consumption of enzyme-inducing drugs within 30 days before the study: carbamazepinam, nevirapine, phenobarbital, rifampin, secobarbital and wort
6) Patients who are taking paracetamol, acetylsalicylic acid, bemiparina, clonixidina, oral anticoagulants, heparin and derivatives, systemic corticosteroids, pemetresed, digoxin, phenytoin, lithium, methotrexate, salicylates, NSAIDs, antacids containing aluminum, as algeldrate, magaldrate, morphine and its derivatives.
Patients who have been medicated with NSAIDs or morphine derivatives for the treatment of TMD pain before attending the consultation will be included, when they meet a washout period of 8 to 12 hours (depending on the medication they have taken) before being included in the study.
7) Patients with underlying systemic disease candidate to receive drug treatment with analgesic.
8) Patients with a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs. Peptic ulcer / active or recurrent gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
9) Patients with Crohn's disease or ulcerative colitis. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
10) Patients with oxalate urolithiasis.
11) Patients with cerebrovascular bleeding or other active bleeding.
12) Patients with bleeding diathesis or other bleeding disorders

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified