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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602483
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : January 19, 2017
Sponsor:
Collaborators:
Universitat Internacional de Catalunya
Hospital Odontològic UB
Hospital Universitario La Fe
Hospital Universitario Rey Juan Carlos
Information provided by (Responsible Party):
Spherium Biomed

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

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Drug: Ibuprofen Drug: Magnesium Drug: Ascorbic Acid Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Triple combination
Powder for oral administration
Drug: Ibuprofen
Drug: Magnesium
Drug: Ascorbic Acid
Active Comparator: Ibuprofen
Powder for oral administration
Drug: Ibuprofen
Active Comparator: Magnesium + ascorbic acid
Powder for oral administration
Drug: Magnesium
Drug: Ascorbic Acid
Placebo Comparator: Placebo
Powder for oral administration
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  1. Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7. [ Time Frame: seven days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602483


Locations
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Spain
Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya
Sant Cugat del Valles, Barcelona, Spain, 08195
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain, 28933
Hospital Odontològic de la Universitat de Barcelona
Barcelona, Spain, 08027
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Spherium Biomed
Universitat Internacional de Catalunya
Hospital Odontològic UB
Hospital Universitario La Fe
Hospital Universitario Rey Juan Carlos
Investigators
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Principal Investigator: Giner Lluis, MD Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña
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Responsible Party: Spherium Biomed
ClinicalTrials.gov Identifier: NCT02602483    
Other Study ID Numbers: JAN12006-01
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Spherium Biomed:
temporomandibular
joint
pain
ibuprofen
magnesium
vitamin C
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Acute Pain
Pain
Neurologic Manifestations
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Ascorbic Acid
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Vitamins
Micronutrients