Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).
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
1 other identifier
interventional
96
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 19, 2017
October 1, 2016
1 year
November 10, 2015
January 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain level from baseline compared to placebo assessed by a pain VAS scale
Pain level is measured according to visual analogue scale (VAS, 0-100 mm) before and 7 days after treatment.
seven days
Secondary Outcomes (1)
Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7.
seven days
Study Arms (4)
Triple combination
EXPERIMENTALPowder for oral administration
Ibuprofen
ACTIVE COMPARATORPowder for oral administration
Magnesium + ascorbic acid
ACTIVE COMPARATORPowder for oral administration
Placebo
PLACEBO COMPARATORPowder for oral administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spherium Biomedlead
- Universitat Internacional de Catalunyacollaborator
- Hospital Odontològic UBcollaborator
- Hospital Universitario La Fecollaborator
- Hospital Universitario Rey Juan Carloscollaborator
Study Sites (4)
Hospital Odontològic de la Universitat de Barcelona
Barcelona, Barcelona, 08027, Spain
Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giner Lluis, MD
Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 11, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 19, 2017
Record last verified: 2016-10