Temporomandibular joint dysfunction syndrome.
Conditions
Interventions
Product Name: FDCJAN12006
Product Code: FDCJAN12006
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: IBUPROFEN D,L-LYSINATE
CAS Number: 57469-76-8
Current Sponsor code: FDCJAN12006-A
Sponsors
Spherium Biomed
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of a triple combination of ibuprofen, magnesium and ascorbic acid (vitamin C) in the treatment of acute pain in TMD compared to placebo.;Secondary Objective: - To explore the efficacy of a triple combination of ibuprofen, magnesium and ascorbic acid (vitamin C) in improving the functionality of the jaw in the temporomandibular disorders (TTMs) compared to placebo. - To explore the efficacy of magnesium and vitamin C in the treatment of acute pain in the temporomandibular (TTMs) disorders compared to placebo. - To explore the effectiveness of magnesium and vitamin C in improving the functionality of the jaw in the temporomandibular (TTMs) disorders compared to placebo.;Primary end point(s): Change in pain severity from baseline and compared to placebo for the triple combination of ibuprofen, magnesium and vitamin C after the 7 days of treatment. Pimary safety end points were based on a comparison of the number, severity and causality of adverse events (AEs) between treatment groups.;Timepoint(s) of evaluation of this end point: After the 7 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Specified above.;Secondary end point(s): • Change in pain intensity from baseline and compared to placebo for the triple combination of ibuprofen, magnesium and vitamin C at 3 days of treatment. • Change in pain intensity from baseline of the triple combination of ibuprofen, magnesium and vitamin C compared to the other three comparators treatments at 3 and 7 days of treatment. • Time to onset of pain relief stable (= 0.5 measured as a reduction in VAS verified points in at least two consecutive assessments and consistent). • Percentage of patients with baseline pain reduction of 10%, 20% and 30% (yes / no), after 3 days of treatment, • Percentage of patients with baseline pain reduction of 10%, 20% and 30% (yes / no), after 7 days of treatment. • Consumption of rescue medication and time to first use of rescue medication for pain . • Evolution in the questionnaire responses RDC / TMD (a clinical examination parameters) collected at baseline, 72 ± 24 h at the final visit at 7 days, comparing the combined treatment group and the placebo two other treatments. The variables in this section will be analyzed in detail are: - Unassisted mandibular opening painless (range of vertical movement) - Joint Sounds - Lateral movements and protrusion - Tenderness of extraoral muscles: temporal - Tenderness of extraoral muscles: masseter - Joint pain on palpation: lateral pole (external) - Joint pain on palpation: Back insert (ear canal) - Tenderness of intraoral muscles: lateral pterygoid (top retromolar area) - Tenderness of intraoral muscles: temporal tendon | — |
Countries
Spain
Contacts
Public ContactNoelia Escalona
Trial Form Support
Outcome results
None listed