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

Spherium Biomed

Status and phase: Completed; Phase 2; Phase 1

Conditions: Temporomandibular Joint Disorders

Treatments: Drug: Magnesium; Drug: Placebo; Drug: Ascorbic Acid; Drug: Ibuprofen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02602483

JAN12006-01

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 4 patient groups, including a placebo group

Triple combination

Experimental group

Description:

Powder for oral administration

Treatment:

Drug: Magnesium

Drug: Ascorbic Acid

Drug: Ibuprofen

Ibuprofen

Active Comparator group

Description:

Powder for oral administration

Treatment:

Drug: Ibuprofen

Magnesium + ascorbic acid

Active Comparator group

Description:

Powder for oral administration

Treatment:

Drug: Magnesium

Drug: Ascorbic Acid

Placebo

Placebo Comparator group

Description:

Powder for oral administration

Treatment:

Drug: Placebo