Non-steroidal Anti-inflammatory PoisoningPhase 2NCT02658799
Effects of a Cyclic NSAID Regimen on Levels of GCF PGE-E2 and IL-1beta
A Phase 2 study testing cataflam (diclofenac potassium) in people with Non-steroidal Anti-inflammatory Poisoning, run by Baskent University.
Trial summary
Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and pain relief. However, while adjunct use of NSAIDs is avoided for periodontal therapy because of related side effects, cyclic administration of NSAIDs may reduce or eliminate these effects. Read more about this study
- Who is it for?
- Ages 32 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-steroidal Anti-inflammatory Poisoning
- What is being tested?
- cataflam (diclofenac potassium)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Dec 2004
- Phase
- Phase 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 32 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- with moderate to chronic periodontal disease
- (at least two sites with loss of clinical attachment > 4mm
- alveolar bone loss of 30-50%, as judged by radiography
- received initial periodontal therapy, including scaling and root planning, as well as oral hygiene instruction less than six weeks before study commencement.
Who cannot join
- history of cardiovascular disease, renal disease, bleeding in the upper gastrointestinal tract, gastrointestinal ulcers, asthma, hypersensitivity to diclofenac or other NSAIDs, prosthetic joint replacement, or other chronic disease affecting compliance
- received antibiotics or antibacterial agents less than 6 months before study commencement
- received NSAIDs within 1 month, or phenytoin or calcium antagonists within 3 months
- history of pregnancy, lactation, or inadequate birth control
About this study
Official title: A Cyclic Regimen of Diclofenac Potassium May be Efficacious in the Management of Chronic Periodontitis in Adults
Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and pain relief. However, while adjunct use of NSAIDs is avoided for periodontal therapy because of related side effects, cyclic administration of NSAIDs may reduce or eliminate these effects. The investigators evaluated the effect of a cyclic diclofenac potassium regimen on clinical parameters and levels of prostaglandin E2 (PGE2) and interleukin-1beta (IL-1beta) in the gingival crevicular fluid (GCF) of subjects with periodontitis. Forty-one subjects with moderate to chronic periodontitis (33 men, 8 women) were divided into two groups (test and control) after initial periodontal therapy. During this 6-month, randomized, double-blind, placebo-controlled study, test (n = 28) and control (n = 13) groups were administered a cyclic regimen of diclofenac potassium (50 mg, twice daily) or placebo. Clinical measurements of disease severity and GCF sample collections were made at baseline, 2, 4 and 6 months. GCF levels of PGE2 and IL1-1beta were determined using EIA and ELISA kits, respectively.
Read the detailed description
Study Design This study utilized a randomized, controlled, double-blind, parallel-group design to investigate the 6-month effect of a cyclic regimen of diclofenac potassium [50 mg, twice daily (b.i.d)] on clinical parameters of periodontal disease and levels of PGE2 and IL-1beta in GCF. After clinical and radiographic examination, subjects were divided into two groups: 28 patients in the test group and 13 patients in the control group. Of the 28 patients in the test group, ten (nine men, one woman) were smokers, eleven (six women, five men) were non-smokers, and seven (all men) were ex-smokers. Thirteen patients in the control group comprised six smokers (five men, one woman), five non-smokers (four women, one man) and two ex-smokers (both men).
Test and control groups were administered either diclofenac potassium (50 mg) or placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose), respectively, b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium or placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. Patients in both groups were instructed on oral hygiene, including tooth brushing for at least 2 minutes (b.i.d.) and daily interdental cleaning. SRP was not carried out during these recalls. During the screening period (baseline as well as 2, 4 and 6 months), all subjects underwent physical examinations and biochemical analyses (blood chemistry, complete blood count, urinalyses and pregnancy testing).
- Being tested
- cataflam (diclofenac potassium), placebo
- Keywords
- periodontitis, anti-inflammatory agents
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataflam (diclofenac potassium)Drug
Also called Cataflam
Cataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.
placeboDrug
Also called placebo gel cap
Placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen.
Administration of placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.
| Study group | Role | What they receive |
|---|---|---|
| diclofenac potassium | Experimental | Cataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen.
Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium) was administered from 2 to 4 months, then diclofenac potassium therapy was reinstituted (b.i.d.) from 4 to 6 months.
To promote compliance, each patient was recalled monthly. Receives: Drug: cataflam (diclofenac potassium) |
| placebo | Active comparator | or placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen.
Administration of placebo was undertaken from baseline to 2 months, no drug (placebo) was administered from 2 to 4 months, then diclofenac potassium therapy was reinstituted (b.i.d.) from 4 to 6 months.
To promote compliance, each patient was recalled monthly. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gingival crevicular fluid levels of prostaglandin E2 by 50 mg diclofenac potassium administration
Administration of diclofenac potassium or placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. Gingival crevicular fluid levels of prostaglandin E2 was measured by using ELISA method, at baseline, 2-month, 4-month and 6-month of the study period.
Measured: Baseline, 2 months, 4 months and 6 months
Changes in gingival crevicular fluid levels of interleukin-1beta by 50 mg diclofenac potassium administration
administration of diclofenac potassium or placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. Gingival crevicular fluid levels of interleukin-1beta were measured by using ELISA method, at baseline, 2-month, 4-month and 6-month of the study period.
Measured: Baseline, 2 months, 4 months and 6 months
Secondary outcomes (4)
Changes in plaque index (PI) by 50 mg diclofenac potassium administration
At baseline, 2-, 4- and 6-month, plaque index (PI) were recorded. Plaque index (PI); 0: no visible plaque, 1: minor plaque accumulation during probing, 2: visible plaque near by gingiva, 3: full plaque accumulation of the tooth.
Measured: Baseline, 2 months, 4 months and 6 months
Changes in gingival index (GI) by 50 mg diclofenac potassium administration
At baseline, 2-, 4- and 6-month, gingival index (GI) were recorded. Gingival index (GI); 0: healthy gingiva, 1: slightly inflammation and no bleeding on probing, 2: moderate gingival inflammation and bleeding on probing, 3: spontaneous bleeding and/or suppuration.
Measured: Baseline, 2 months, 4 months and 6 months
Changes in probing depth (PD) by 50 mg diclofenac potassium administration
At baseline, 2-, 4- and 6-month, probing depth (PD) were recorded. Probing depth (PD): with William's periodontal probe, distance between gingival margin to bottom of the sulcus).
Measured: Baseline, 2 months, 4 months and 6 months
Changes in probing clinical attachment level by 50 mg diclofenac potassium administration
At baseline, 2-, 4- and 6-month, clinical attachment level (CAL) were recorded. Clinical attachment level (CAL); with William's periodontal probe, distance between enamel-cement junction to bottom of the sulcus).
Measured: Baseline, 2 months, 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2000
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-steroidal Anti-inflammatory PoisoningStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün Özlem Alptekin, Baskent University
- Investigators
- Bahar Füsun Oduncuoğlu, DDSPhD, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658799
- Sponsor's protocol ID
- 2000/071
- Status last verified
- Jan 2016
- First submitted
- 9 Jan 2016
- Last updated
- 20 Jan 2016
- 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 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cyclic Regimen of Diclofenac Potassium May be Efficacious in the Management of Chronic Periodontitis in Adults
- ClinicalTrials.gov ID
- NCT02658799
- Acronym / sponsor ID
- 2000/071
- Keywords
- periodontitis, anti-inflammatory agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 20 Jan 2016 (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.
Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and pain relief. However, while adjunct use of NSAIDs is avoided for periodontal therapy because of related side effects, cyclic administration of NSAIDs may reduce or eliminate these effects. The investigators evaluated the effect of a cyclic diclofenac potassium regimen on clinical parameters and levels of prostaglandin E2 (PGE2) and interleukin-1beta (IL-1beta) in the gingival crevicular fluid (GCF) of subjects with periodontitis. Forty-one subjects with moderate to chronic periodontitis (33 men, 8 women) were divided into two groups (test and control) after initial periodontal therapy. During this 6-month, randomized, double-blind, placebo-controlled study, test (n = 28) and control (n = 13) groups were administered a cyclic regimen of diclofenac potassium (50 mg, twice daily) or placebo. Clinical measurements of disease severity and GCF sample collections were made at baseline, 2, 4 and 6 months. GCF levels of PGE2 and IL1-1beta were determined using EIA and ELISA kits, respectively.
Detailed description
Study Design This study utilized a randomized, controlled, double-blind, parallel-group design to investigate the 6-month effect of a cyclic regimen of diclofenac potassium [50 mg, twice daily (b.i.d)] on clinical parameters of periodontal disease and levels of PGE2 and IL-1beta in GCF. After clinical and radiographic examination, subjects were divided into two groups: 28 patients in the test group and 13 patients in the control group. Of the 28 patients in the test group, ten (nine men, one woman) were smokers, eleven (six women, five men) were non-smokers, and seven (all men) were ex-smokers. Thirteen patients in the control group comprised six smokers (five men, one woman), five non-smokers (four women, one man) and two ex-smokers (both men).
Test and control groups were administered either diclofenac potassium (50 mg) or placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose), respectively, b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium or placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. Patients in both groups were instructed on oral hygiene, including tooth brushing for at least 2 minutes (b.i.d.) and daily interdental cleaning. SRP was not carried out during these recalls. During the screening period (baseline as well as 2, 4 and 6 months), all subjects underwent physical examinations and biochemical analyses (blood chemistry, complete blood count, urinalyses and pregnancy testing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diclofenac potassium | Experimental | Drug: cataflam (diclofenac potassium)Cataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium) was administered from 2 to 4 months, then diclofenac potassium therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. |
| placebo | Active comparator | Drug: placeboor placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of placebo was undertaken from baseline to 2 months, no drug (placebo) was administered from 2 to 4 months, then diclofenac potassium therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. |
Who may qualify
- Ages
- 32 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- with moderate to chronic periodontal disease
- (at least two sites with loss of clinical attachment > 4mm
- alveolar bone loss of 30-50%, as judged by radiography
- received initial periodontal therapy, including scaling and root planning, as well as oral hygiene instruction less than six weeks before study commencement.
Key exclusion criteria (4 listed)
- history of cardiovascular disease, renal disease, bleeding in the upper gastrointestinal tract, gastrointestinal ulcers, asthma, hypersensitivity to diclofenac or other NSAIDs, prosthetic joint replacement, or other chronic disease affecting compliance
- received antibiotics or antibacterial agents less than 6 months before study commencement
- received NSAIDs within 1 month, or phenytoin or calcium antagonists within 3 months
- history of pregnancy, lactation, or inadequate birth control
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 |
|---|---|---|
| cataflam (diclofenac potassium)Also: CataflamCataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. | Drug | diclofenac potassium |
| placeboAlso: placebo gel capPlacebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly. | Drug | placebo |
Primary outcome
Changes in gingival crevicular fluid levels of prostaglandin E2 by 50 mg diclofenac potassium administration
Time frame: Baseline, 2 months, 4 months and 6 months
Administration of diclofenac potassium or placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. Gingival crevicular fluid levels of prostaglandin E2 was measured by using ELISA method, at baseline, 2-month, 4-month and 6-month of the study period.
Changes in gingival crevicular fluid levels of interleukin-1beta by 50 mg diclofenac potassium administration
Time frame: Baseline, 2 months, 4 months and 6 months
administration of diclofenac potassium or placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. Gingival crevicular fluid levels of interleukin-1beta were measured by using ELISA method, at baseline, 2-month, 4-month and 6-month of the study period.
4 secondary outcomes
Changes in plaque index (PI) by 50 mg diclofenac potassium administration
Time frame: Baseline, 2 months, 4 months and 6 months
Changes in gingival index (GI) by 50 mg diclofenac potassium administration
Time frame: Baseline, 2 months, 4 months and 6 months
Changes in probing depth (PD) by 50 mg diclofenac potassium administration
Time frame: Baseline, 2 months, 4 months and 6 months
Changes in probing clinical attachment level by 50 mg diclofenac potassium administration
Time frame: Baseline, 2 months, 4 months and 6 months
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 20 Jan 2016.
- Individual participant dataSharing planned: Undecided
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.
Bahar Füsun Oduncuoğlu, DDSPhD principal investigator
Baskent University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cataflam (diclofenac potassium) in people with Non-steroidal Anti-inflammatory Poisoning, run by Baskent University.
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 4 inclusion and 4 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Changes in gingival crevicular fluid levels of prostaglandin E2 by 50 mg diclofenac potassium administration (time frame: Baseline, 2 months, 4 months and 6 months). The study lists 2 primary outcomes in all. 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 20 Jan 2016.