Temporomandibular Joint DisordersPhase 1/2NCT02602483
Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).
A Phase 1/2 study testing Ibuprofen, Magnesium and Ascorbic Acid in people with Temporomandibular Joint Disorders, run by Spherium Biomed at 4 sites in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Ibuprofen, Magnesium and Ascorbic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 4 sitesSpain
- Study dates
- Dec 2015to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Subjects between 18 and 65 years.
- Body weight within the normal range (IMC index between 19 and 30) expressed as weight (kg) /height (m2).
- Physical condition according to ASA I or II (American Society of Anesthesiologists)
- Having not participated in previous clinical trial during the three months preceding the setting-up of this study.
- Free acceptance to collaborate in the study, expressed by signature of written informed consent by the participant
Who cannot join
- Patients who are pregnant or breastfeeding.
- 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.
- 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.
- Patients with underlying systemic pathology candidate to receive drug treatment with analgesic.
- 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.
Show all 11Show fewer
- Patients with active Ulcerative colitis or Crohn's disease. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
- Patients with urolithiasis by oxalate
- 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.
- Heavy consumer of stimulating beverages (>5 coffees, teas, or cola drinks per day).
- 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 locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Odontològic de la Universitat de Barcelona
Barcelona, Barcelona, 08027
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
About this study
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
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
- Being tested
- Ibuprofen, Magnesium, Ascorbic Acid, Placebo
- Keywords
- temporomandibular, joint, pain, ibuprofen, magnesium, vitamin C
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
MagnesiumDrug
Ascorbic AcidDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Triple combination | Experimental | Powder for oral administration Receives: Drug: Ibuprofen; Drug: Magnesium; Drug: Ascorbic Acid |
| Ibuprofen | Active comparator | Powder for oral administration Receives: Drug: Ibuprofen |
| Magnesium + ascorbic acid | Active comparator | Powder for oral administration Receives: Drug: Magnesium; Drug: Ascorbic Acid |
| Placebo | Placebo comparator | Powder for oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: seven days
Secondary outcomes (1)
Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7.
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spherium Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitat Internacional de Catalunya, Hospital Odontològic UB, Hospital Universitario La Fe, Hospital Universitario Rey Juan Carlos
- Responsible party
- Sponsor
- Investigators
- Giner Lluis, MD, Principal investigator, Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602483
- Sponsor's protocol ID
- JAN12006-01
- Status last verified
- Oct 2016
- First submitted
- 10 Nov 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02602483
- Acronym / sponsor ID
- JAN12006-01
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- temporomandibular, joint, pain, ibuprofen, magnesium, vitamin C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Spherium BiomedIndustry (pharma, biotech, devices)
- Collaborators
- Universitat Internacional de Catalunya, Hospital Odontològic UB, Hospital Universitario La Fe, Hospital Universitario Rey Juan Carlos
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triple combination | Experimental | Drug: Ibuprofen, Drug: Magnesium, Drug: Ascorbic AcidPowder for oral administration |
| Ibuprofen | Active comparator | Drug: IbuprofenPowder for oral administration |
| Magnesium + ascorbic acid | Active comparator | Drug: Magnesium, Drug: Ascorbic AcidPowder for oral administration |
| Placebo | Placebo comparator | Drug: PlaceboPowder for oral administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- Subjects between 18 and 65 years.
- Body weight within the normal range (IMC index between 19 and 30) expressed as weight (kg) /height (m2).
- Physical condition according to ASA I or II (American Society of Anesthesiologists)
- Having not participated in previous clinical trial during the three months preceding the setting-up of this study.
Key exclusion criteria (11 listed)
- Patients who are pregnant or breastfeeding.
- 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.
- 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.
- Patients with underlying systemic pathology candidate to receive drug treatment with analgesic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen | Drug | Ibuprofen, Triple combination |
| Magnesium | Drug | Magnesium + ascorbic acid, Triple combination |
| Ascorbic Acid | Drug | Magnesium + ascorbic acid, Triple combination |
| Placebo | Drug | Placebo |
Primary outcome
Pain level from baseline compared to placebo assessed by a pain VAS scale
Time frame: seven days
Pain level is measured according to visual analogue scale (VAS, 0-100 mm) before and 7 days after treatment.
1 secondary outcome
Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7.
Time frame: seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giner Lluis, MD principal investigator
Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibuprofen, Magnesium and Ascorbic Acid in people with Temporomandibular Joint Disorders, run by Spherium Biomed at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level from baseline compared to placebo assessed by a pain VAS scale (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.