Orofacial PainPhase 4NCT03221946
A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain
A Phase 4 study testing Diclofenac Sodium and Diclofenac in people with Orofacial Pain, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
Newer drug delivery systems such as transdermal patches using pain relieving or modifying agents emerged as mainstream treatment protocol for management of pain on the outpatient basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orofacial Pain
- What is being tested?
- Diclofenac Sodium and Diclofenac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 31 Jan 2016to 15 Sep 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with oral and dental pain due to pulp and periapical pathology
- patients not allergic to any form of medications in terms of NSAIDs.
Who cannot join
- Unwilling and unconscious patients
- patients with cellulitis and spreading oral infections
- patients allergic to non steroidal anti inflammatory agents
- patients with kidney and liver diseases
- patients with blood disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain: A Randomized Control Trial
Newer drug delivery systems such as transdermal patches using pain relieving or modifying agents emerged as mainstream treatment protocol for management of pain on the outpatient basis. The administration of Diclofenac 100 mg in transdermal patch in the patients having dental pain due to periapical/periodontal infections was evaluated.
Methods: 90 Patients of either gender, between 18 to 80 years were divided into 3 groups (Group A- oral medication, Group B- transdermal patch, Group C - intra muscular group). Patients at the dental department with pain from periapical/periodontal pathologies were explained about the procedure of analgesia. With written consent, 100 mg diclofenac sodium transdermal patches were prescribed to patients who opted their use in pain control for 2 consecutive days. A Visual Analog Scale was provided for all patients assessing the pain intensity during the study.
Read the detailed description
Transdermal Patches ensure simple, painless procedure of drug usage even in patients with needle phobia. they are on par with sustainable plasma levels comparable with that of oral medication. With the local drug delivery method, hepatic first pass metabolism is bypassed. Offering increased flexibility in placing and removing the transdermal patch better patient compliance is achieved.
This study was carried out comparing the efficacy of analgesia, occurrence of side effects from the drugs employed and patient compliance during the drug usage with diclofenac sodium trans dermal patch 100 mg, oral supplementation of diclofenac sodium 50 mg given as twice daily medication and intra muscular administration of 75 mg diclofenac sodium once daily for two days in patients having dental pain due to periapical or periodontal pathology.
Material and Methods
A total sample of 90 subjects of either gender, between 18 to 80 years attending Department of Oral Medicine \& Radiology with dental pain and who were willing to be part of the study were included and divided randomly into 3 groups based on their preference and priority of the route of administration of the drug. As this was a pilot study, a sample size of 90 was chosen according to recommendations by Isaac and Michael, W. B
The study was cleared by ethical clearance committee with necessary approvals. the subjects were informed thoroughly about the study and could withdraw from the study at their choice when there is no relief of pain with the medication.
The groups included in the study were:
Group A which included 30 patients of either gender who were prescribed tablet Diclofenac sodium 50 mg orally twice daily for 2 days which is the preferred adult dose for dental pain disorders
Group B which included 30 patients who were prescribed Diclofenac sodium 100mg transdermal patch to equate the oral dosage of 50mg that is given twice daily once daily for 2 days ( SPARSH PHARMA). It is a transparent patch that gave sustained release of the drug for 24 hours at the local site applied. A total number of 2 patches were given to each patient one per day. The patches were applied at an hairless area on the left or right shoulders which were subsequently replaced the next day to another area of application in order to avoid contact dermatitis in the area of application.
Group C which included 30 patients of either gender who were given intra muscular injection of 75mg which was the nearest available dosage to 100mg availability in India at deltoid or gluteus muscle once daily for 2 days using sterile and aseptic precautions.
All the subjects were prescribed necessary antibiotics for reduction in peri apical /periodontal infections. The rescue medication tablet chosen was Paracetamol 325 mg, if any of the patients opted for further medication for pain relief. Also, a visual analog scale was provided to all the subjects during their presentation to the hospital for 2 consecutive days for treatment. the scales were obtained in all the subjects individually assessing the intensity of pain after the medication intake during the study period. Team of six doctors evaluated the patients in the study. 2 physicians were assigned the task of data collection from the study participants and assigning them into the group chosen by the patients themselves. 2 physicians had evaluated the patients VAS scores clinically and administered the necessary medication to the patients and rest of the doctors had evaluated the patients at each visit, making a note of inter observer variability. The enquiry of following adverse effects were noted from all 3 groups.
Group A: Rash, Itch, Gastritis
Group B: Rash at the delivery site, adherence of patch
Group C: Pain at injection site, Nerve palsy, Hypersensitivity reactions.
- Conditions
- Orofacial Pain
- Being tested
- Diclofenac Sodium, Diclofenac
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
Also called Voveran
tablet of 50mg,
Diclofenac sodiumDrug
Also called Sparsh
Transdermal patch 100 mg
DiclofenacDrug
Also called dicloran
intra muscular injection 100mg
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac sodium oral | Active comparator | Group A which included 30 patients of either gender. Dosage drug: Diclofenac sodium Dosage form: Oral medication Frequency: twice daily Dose: 50mg Duration: 2 days Receives: Drug: Diclofenac Sodium |
| diclofenac sodium patch | Experimental | Group B which included 30 patients who were prescribed Drug: Diclofenac sodium Dose: 100mg Drug form: transdermal patch to equate the oral dosage of 50mg Duration: for 2 days Frequency: Once daily Receives: Drug: Diclofenac sodium |
| Diclofenac sodium injection | Other | Group C which included 30 patients of either gender Drug: diclofenac sodium intra muscular injections Dose: 75mg which was the nearest available dosage to 100 mg availability in India Frequency: once daily Duration: for 2 days Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception scale
Measurement of pain on Visual Analog scale scores in all three groups
Measured: 2 days
Secondary outcomes (1)
Patient compliance - Self reported daily catalog
Self reported by patients themselves on their compliance with oral medication, transdermal patch and intra muscular injection
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start31 Jan 2016
- Primary completion1 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arms with 3 groups of 30 patients each evaluated for diclofenac sodium oral tablets, transdermal patch and injection of same drug for dental pain disorders
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NALLAN CHAITANYA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221946
- Sponsor's protocol ID
- PMVIDS&RC/IEC/OMR/PR 0051-15
- Status last verified
- Dec 2017
- First submitted
- 12 Jul 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03221946
- Acronym / sponsor ID
- PMVIDS&RC/IEC/OMR/PR 0051-15
- Conditions
- Orofacial Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 19 Jul 2017 (actual)
- 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.
Newer drug delivery systems such as transdermal patches using pain relieving or modifying agents emerged as mainstream treatment protocol for management of pain on the outpatient basis. The administration of Diclofenac 100 mg in transdermal patch in the patients having dental pain due to periapical/periodontal infections was evaluated.
Methods: 90 Patients of either gender, between 18 to 80 years were divided into 3 groups (Group A- oral medication, Group B- transdermal patch, Group C - intra muscular group). Patients at the dental department with pain from periapical/periodontal pathologies were explained about the procedure of analgesia. With written consent, 100 mg diclofenac sodium transdermal patches were prescribed to patients who opted their use in pain control for 2 consecutive days. A Visual Analog Scale was provided for all patients assessing the pain intensity during the study.
Detailed description
Transdermal Patches ensure simple, painless procedure of drug usage even in patients with needle phobia. they are on par with sustainable plasma levels comparable with that of oral medication. With the local drug delivery method, hepatic first pass metabolism is bypassed. Offering increased flexibility in placing and removing the transdermal patch better patient compliance is achieved.
This study was carried out comparing the efficacy of analgesia, occurrence of side effects from the drugs employed and patient compliance during the drug usage with diclofenac sodium trans dermal patch 100 mg, oral supplementation of diclofenac sodium 50 mg given as twice daily medication and intra muscular administration of 75 mg diclofenac sodium once daily for two days in patients having dental pain due to periapical or periodontal pathology.
Material and Methods
A total sample of 90 subjects of either gender, between 18 to 80 years attending Department of Oral Medicine \& Radiology with dental pain and who were willing to be part of the study were included and divided randomly into 3 groups based on their preference and priority of the route of administration of the drug. As this was a pilot study, a sample size of 90 was chosen according to recommendations by Isaac and Michael, W. B
The study was cleared by ethical clearance committee with necessary approvals. the subjects were informed thoroughly about the study and could withdraw from the study at their choice when there is no relief of pain with the medication.
The groups included in the study were:
Group A which included 30 patients of either gender who were prescribed tablet Diclofenac sodium 50 mg orally twice daily for 2 days which is the preferred adult dose for dental pain disorders
Group B which included 30 patients who were prescribed Diclofenac sodium 100mg transdermal patch to equate the oral dosage of 50mg that is given twice daily once daily for 2 days ( SPARSH PHARMA). It is a transparent patch that gave sustained release of the drug for 24 hours at the local site applied. A total number of 2 patches were given to each patient one per day. The patches were applied at an hairless area on the left or right shoulders which were subsequently replaced the next day to another area of application in order to avoid contact dermatitis in the area of application.
Group C which included 30 patients of either gender who were given intra muscular injection of 75mg which was the nearest available dosage to 100mg availability in India at deltoid or gluteus muscle once daily for 2 days using sterile and aseptic precautions.
All the subjects were prescribed necessary antibiotics for reduction in peri apical /periodontal infections. The rescue medication tablet chosen was Paracetamol 325 mg, if any of the patients opted for further medication for pain relief. Also, a visual analog scale was provided to all the subjects during their presentation to the hospital for 2 consecutive days for treatment. the scales were obtained in all the subjects individually assessing the intensity of pain after the medication intake during the study period. Team of six doctors evaluated the patients in the study. 2 physicians were assigned the task of data collection from the study participants and assigning them into the group chosen by the patients themselves. 2 physicians had evaluated the patients VAS scores clinically and administered the necessary medication to the patients and rest of the doctors had evaluated the patients at each visit, making a note of inter observer variability. The enquiry of following adverse effects were noted from all 3 groups.
Group A: Rash, Itch, Gastritis
Group B: Rash at the delivery site, adherence of patch
Group C: Pain at injection site, Nerve palsy, Hypersensitivity reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 arms with 3 groups of 30 patients each evaluated for diclofenac sodium oral tablets, transdermal patch and injection of same drug for dental pain disorders
| Arm | Type | Receives |
|---|---|---|
| Diclofenac sodium oral | Active comparator | Drug: Diclofenac SodiumGroup A which included 30 patients of either gender. Dosage drug: Diclofenac sodium Dosage form: Oral medication Frequency: twice daily Dose: 50mg Duration: 2 days |
| diclofenac sodium patch | Experimental | Drug: Diclofenac sodiumGroup B which included 30 patients who were prescribed Drug: Diclofenac sodium Dose: 100mg Drug form: transdermal patch to equate the oral dosage of 50mg Duration: for 2 days Frequency: Once daily |
| Diclofenac sodium injection | Other | Drug: DiclofenacGroup C which included 30 patients of either gender Drug: diclofenac sodium intra muscular injections Dose: 75mg which was the nearest available dosage to 100 mg availability in India Frequency: once daily Duration: for 2 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with oral and dental pain due to pulp and periapical pathology
- patients not allergic to any form of medications in terms of NSAIDs.
Key exclusion criteria (5 listed)
- Unwilling and unconscious patients
- patients with cellulitis and spreading oral infections
- patients allergic to non steroidal anti inflammatory agents
- patients with kidney and liver diseases
- patients with blood disorders
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 |
|---|---|---|
| Diclofenac SodiumAlso: Voverantablet of 50mg, | Drug | Diclofenac sodium oral |
| Diclofenac sodiumAlso: SparshTransdermal patch 100 mg | Drug | diclofenac sodium patch |
| DiclofenacAlso: dicloranintra muscular injection 100mg | Drug | Diclofenac sodium injection |
Primary outcome
Pain Perception scale
Time frame: 2 days
Measurement of pain on Visual Analog scale scores in all three groups
1 secondary outcome
Patient compliance - Self reported daily catalog
Time frame: 2 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 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac Sodium and Diclofenac in people with Orofacial Pain, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
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 2 inclusion and 5 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 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Perception scale (time frame: 2 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 Dec 2017.