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

Spherium Biomed4 sites in 1 country96 target enrollmentDecember 2015

ConditionsTemporomandibular Joint Disorders

InterventionsIbuprofen Magnesium Ascorbic Acid Placebo

Overview

Phase: Phase 1
Intervention: Ibuprofen
Conditions: Temporomandibular Joint Disorders
Sponsor: Spherium Biomed
Enrollment: 96
Locations: 4
Primary Endpoint: Pain level from baseline compared to placebo assessed by a pain VAS scale
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

December 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Spherium Biomed

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)
•Subjects between 18 and 65 years.
•Body weight within the normal range (IMC index between 19 and 30) expressed as weight (kg) /height (m2).
•Physical condition according to ASA I or II (American Society of Anesthesiologists)
•Having not participated in previous clinical trial during the three months preceding the setting-up of this study.
•Free acceptance to collaborate in the study, expressed by signature of written informed consent by the participant

Exclusion Criteria

•Patients who are pregnant or breastfeeding.
•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.
•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.
•Patients with underlying systemic pathology candidate to receive drug treatment with analgesic.
•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.
•Patients with active Ulcerative colitis or Crohn's disease. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
•Patients with urolithiasis by oxalate
•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.
•Heavy consumer of stimulating beverages (\>5 coffees, teas, or cola drinks per day).