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

NCT ID: NCT02602483

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-31

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

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Triple combination

Powder for oral administration

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

Magnesium

Intervention Type: DRUG

Ascorbic Acid

Intervention Type: DRUG

Ibuprofen

Powder for oral administration

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Magnesium + ascorbic acid

Powder for oral administration

Group Type: ACTIVE_COMPARATOR

Magnesium

Intervention Type: DRUG

Ascorbic Acid

Intervention Type: DRUG

Placebo

Powder for oral administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Ibuprofen

Intervention Type: DRUG

Magnesium

Intervention Type: DRUG

Ascorbic Acid

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: collaborator

Hospital Odontològic UB

OTHER

Sponsor Role: collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role: collaborator

Hospital Universitario Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Spherium Biomed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giner Lluis, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña

Locations

Hospital Odontològic de la Universitat de Barcelona

Barcelona, Barcelona, Spain

Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

JAN12006-01

Identifier Type: -

Identifier Source: org_study_id