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Completed

NCT Number: NCT02602483

Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Odontològic de la Universitat de Barcelona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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 .

Treatment and study plan

Ibuprofen

Drug

Magnesium

Drug

ascorbic acid

Drug

Placebo

Drug

Primary outcomes

  1. Pain level from baseline compared to placebo assessed by a pain VAS scale

    Time frame: seven days

    Pain level is measured according to visual analogue scale (VAS, 0-100 mm) before and 7 days after treatment.

Secondary outcomes

  1. Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7.

    Time frame: seven days

Sponsors and collaborators

Lead sponsor

Spherium Biomed

Industry

Collaborators

  • Hospital Odontològic UB
  • Hospital Universitario La Fe
  • Hospital Universitario Rey Juan Carlos
  • Universitat Internacional de Catalunya

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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