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

January 18, 2017 updated by: Spherium Biomed

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08027
        • Hospital Odontològic de la Universitat de Barcelona
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Barcelona
      • Sant Cugat del Valles, Barcelona, Spain, 08195
        • Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya
    • Madrid
      • Móstoles, Madrid, Spain, 28933
        • Hospital Universitario Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
seven days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spherium Biomed

Collaborators

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

Investigators

  • Principal Investigator: Giner Lluis, MD, Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAN12006-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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