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

Phase 1

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Drug: Magnesium; Drug: Ibuprofen; Drug: Placebo; Drug: Ascorbic Acid

• Registration Number: NCT02602483
• Lead Sponsor: Spherium Biomed

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Study Start: 2015-12
• Status Verified: 2016-10
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

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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 .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium + ascorbic acid	Magnesium	Powder for oral administration
Triple combination	Ibuprofen	Powder for oral administration
Triple combination	Ascorbic Acid	Powder for oral administration
Ibuprofen	Ibuprofen	Powder for oral administration
Placebo	Placebo	Powder for oral administration
Magnesium + ascorbic acid	Ascorbic Acid	Powder for oral administration
Triple combination	Magnesium	Powder for oral administration

Primary Outcome Measures

Name	Time	Method
Pain level from baseline compared to placebo assessed by a pain VAS scale	seven days	Pain level is measured according to visual analogue scale (VAS, 0-100 mm) before and 7 days after treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Hospital Universitario Rey Juan Carlos; 🇪🇸 Móstoles, Madrid, Spain

Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain

Hospital Odontològic de la Universitat de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain