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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02602483
• Date of registration: 10/11/2015
• Prospective Registration: Yes
• Primary sponsor: Spherium Biomed
• Public title: Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).
• Scientific 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
• Date of first enrolment: December 2015
• Target sample size: 96
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02602483
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Spain

Contacts

• Name: Giner Lluis, MD
• Affiliation: Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña

Key inclusion & exclusion 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 .



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Temporomandibular Joint Disorders

Intervention(s)

Drug: Ascorbic Acid

Drug: Ibuprofen

Drug: Magnesium

Drug: Placebo

Primary Outcome(s)

Pain level from baseline compared to placebo assessed by a pain VAS scale [Time Frame: seven days]

Secondary Outcome(s)

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

Secondary ID(s)

JAN12006-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universitat Internacional de Catalunya

Hospital Odontològic UB

Hospital Universitario La Fe

Hospital Universitario Rey Juan Carlos