Clinical trial NCT02602483: Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).
Official title: Randomized, Double Blind, Placebo Controlled Exploratory Study To Assess the Efficacy and Safety of a Triple Combination of Ibuprofen+Mg+Ascorbic Acid for Acute Pain Treatment in Temporomandibular Join Disorder (TMJD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Temporomandibular Joint Disorders
Keywords: temporomandibular
joint
pain
ibuprofen
magnesium
vitamin C
Lead sponsor: Spherium Biomed
Sponsor class: INDUSTRY
Collaborators: name: Universitat Internacional de Catalunya
name: Hospital Odontològic UB
name: Hospital Universitario La Fe
name: Hospital Universitario Rey Juan Carlos
First posted: 2015-11-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objetive of this study is to explore the efficacy and safety of a triple combination of ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients


Eligibility criteria: Inclusion Criteria:

1. TMD dysfunction syndrome patients of RDC/TMD Groups Ia and/or Ib (+/- IIIa and/or IIIb); with moderate to severe pain (VAS \>4), refractory to conservative treatment (including splint / local prosthesis)
2. Subjects between 18 and 65 years.
3. Body weight within the normal range (IMC index between 19 and 30) expressed as weight (kg) /height (m2).
4. Physical condition according to ASA I or II (American Society of Anesthesiologists)
5. Having not participated in previous clinical trial during the three months preceding the setting-up of this study.
6. Free acceptance to collaborate in the study, expressed by signature of written informed consent by the participant

Exclusion Criteria:

1. Patients who are pregnant or breastfeeding.
2. Patients who have a consumption of enzyme-inducing drugs within the 30 days prior to the study: carbamazepinam, nevirapine, phenobarbital, rifampin, secobarbital and St. John's wort.
3. Patients who are consuming: acetaminophen, acetyl salicylic acid, bemiparina, clonixidina, oral anticoagulant, heparin and derivatives, systemic corticosteroids, pemetresed, digoxin, phenytoin, lithium, methotrexate, Salicylates, NSAIDs, antacids containing aluminum, such as algeldrato, magaldrate, morphine and its derivatives.

   Patients who have been medicated with NSAIDs or Morphic derivatives for the treatment of pain of TMD prior to attending the consultation will be included whether, they meet a washout period of 8 to 12 hours (depending on the medication taken) before being included in the study.
4. Patients with underlying systemic pathology candidate to receive drug treatment with analgesic.
5. In patients with a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs. Peptic ulcer / active or recurrent gastrointestinal hemorrhage (two or more episodes of ulceration) or proven hemorrhage.
6. Patients with active Ulcerative colitis or Crohn's disease. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
7. Patients with urolithiasis by oxalate
8. History of alcoholism or drug dependence within 3 months prior to the screening visit, and / or, History of psychotropic drugs consumption within 3 months prior to the screening visit.
9. Heavy consumer of stimulating beverages (\>5 coffees, teas, or cola drinks per day).
10. History of drug allergy, idiosyncrasy or hypersensitivity. 11 Patients with cerebrovascular bleeding or other active bleeding 12 Patients with bleeding diathesis or other bleeding disorders .

Primary outcomes:
measure: Pain level from baseline compared to placebo assessed by a pain VAS scale
timeFrame: seven days
Secondary outcomes:
measure: Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7.
timeFrame: seven days
Other outcomes:
Locations:
city: Sant Cugat del Valles
country: Spain
facility: Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya
state: Barcelona
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Odontològic de la Universitat de Barcelona
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
affiliation: Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña
name: Giner Lluis, MD
role: PRINCIPAL_INVESTIGATOR
References: