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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

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date January 19, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Daily change from baseline compared to placebo assessed by a pain VAS scale [ Time Frame: seven days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7. [ Time Frame: seven days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Temporomandibular Joint Disorders
Intervention  ICMJE
  • Drug: Ibuprofen
  • Drug: Magnesium
  • Drug: Ascorbic Acid
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Triple combination
    Powder for oral administration
    Interventions:
    • Drug: Ibuprofen
    • Drug: Magnesium
    • Drug: Ascorbic Acid
  • Active Comparator: Ibuprofen
    Powder for oral administration
    Intervention: Drug: Ibuprofen
  • Active Comparator: Magnesium + ascorbic acid
    Powder for oral administration
    Interventions:
    • Drug: Magnesium
    • Drug: Ascorbic Acid
  • Placebo Comparator: Placebo
    Powder for oral administration
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2015)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02602483
Other Study ID Numbers  ICMJE JAN12006-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Spherium Biomed
Study Sponsor  ICMJE Spherium Biomed
Collaborators  ICMJE
  • Universitat Internacional de Catalunya
  • Hospital Odontològic UB
  • Hospital Universitario La Fe
  • Hospital Universitario Rey Juan Carlos
Investigators  ICMJE
Principal Investigator: Giner Lluis, MD Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña
PRS Account Spherium Biomed
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP