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

Temporomandibular Joint Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602483
• Other study ID #: JAN12006-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 10, 2015
• Last updated: January 18, 2017
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Spherium Biomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Acute Pain
• Disease
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Ibuprofen

• Magnesium

• Ascorbic Acid

• Placebo

Locations

Country	Name	City	State
Spain	Hospital Odontològic de la Universitat de Barcelona	Barcelona
Spain	Hospital Universitario Rey Juan Carlos	Móstoles	Madrid
Spain	Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya	Sant Cugat del Valles	Barcelona
Spain	Hospital Universitari i Politècnic La Fe	Valencia

Sponsors (5)

Lead Sponsor	Collaborator
Spherium Biomed	Hospital Odontològic UB, Hospital Universitario La Fe, Hospital Universitario Rey Juan Carlos, Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level from baseline compared to placebo assessed by a pain VAS scale	Pain level is measured according to visual analogue scale (VAS, 0-100 mm) before and 7 days after treatment.	seven days
Secondary	Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7.		seven days