Acute Dental PainPhase 1NCT01339156
Study of P3914 to Evaluate the Safety, Tolerability, Food Effect & Pharmacokinetics in Healthy Male Subjects and Efficacy & Safety of P3914 in Patients With Acute Dental Pain
A Phase 1 study testing P3914 in people with Acute Dental Pain, run by Piramal Enterprises Limited.
Trial summary
P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a NO moiety is intended for the treatment of pain and inflammation. The rationale behind development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory activity of naproxen and enhance GI safety by virtue of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Dental Pain
- What is being tested?
- P3914
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- for Part A, Part B and Part C
- Male subjects aged between 18 and 45 years (including both) with Body Mass Index between 18 to 25 kg/m2 (including both).
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable X-Ray chest (P/A view).
- Subjects having clinically acceptable endoscopy.
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- Have a negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- Have negative alcohol breath test.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- Part D:
- Patients with acute postoperative dental pain (at least moderate in severity or score of 40 mm on VAS) after removal of an impacted third mandibular molar will be selected for study participation, if they meet the following criteria:
- Male patients aged between 18 and 60 years (including both).
- Patients with acute postoperative dental pain (at least moderate in severity or score of 40 mm on Visual Analogue Scale)
- Patients with otherwise normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- Patients having clinically acceptable 12-lead electrocardiogram (ECG).
- Patients having clinically acceptable chest X-Ray (P/A view).
- Patients having clinically acceptable endoscopy.
- Have a negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- Have negative alcohol breath test.
- Patients willing to adhere to the protocol requirements and to provide written informed consent.
Who cannot join
- Part A, Part B and Part C:
- Hypersensitivity to NSAIDs or nitrodonating drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of the study starting.
- History or presence of significant gastric and/or duodenal ulceration including the last three months or gastroduodenal bleeding including the last six months prior to the screening visit.
- History of peptic ulceration or significant dyspepsia as judged by the investigator.
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- Endoscopy finding of gastric or duodenal ulcer at baseline. Erosive esophagitis or other endoscopic appearance that constitutes a risk to the subject, if included in the study, as judged by the investigator.
- Have positive test for Helicobacter pylori infection.
- Orthostatic hypotension with a systolic blood pressure drop of ≥ 25 mm Hg and/or a diastolic blood pressure drop of ≥ 15 mm Hg within 5 minutes of standing when changing from supine to erect position.
- A history of renal impairment, or a glomerular filtration rate (GFR) <60 mL/min or, at visit 1, a serum creatinine value >140 mol/L.
- Use of aspirin, H2 antagonists, antacids, misoprostol, proton pump inhibitors, sucralfate including two weeks prior to the screening visit.
- Subjects currently taking sildenafil, anticoagulants or ticlopidine, nitrates, nitrovasodilating drugs (e.g. nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, glycerin trinitrate), diuretics (in a dose potentially leading to volume depletion).
- Use of any prescribed medication during last two weeks or OTC medicinal products (including herbal/traditional medicine preparations) during the last one week prior to initiation of study.
- History or presence of significant alcoholism or drug abuse in the past one year.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of smoking or use of other tobacco, pan, gutkha products since last six months.
- History or presence of significant asthma, urticaria or other allergic reactions.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- Difficulty in swallowing solids like tablets or capsules.
- History or presence of cancer.
- Difficulty with donating blood.
- Major illness during three months before screening.
- Participation in a drug research study within past three months.
- Donation of blood in the past three months before screening.
- For Part D:
- Hypersensitivity to NSAIDs or nitrodonating drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- History or presence of significant gastric and/or duodenal ulceration including the last three months or gastroduodenal bleeding including the last six months prior to the screening visit.
- History of peptic ulceration or significant dyspepsia as judged by the investigator.
- Endoscopy finding of gastric or duodenal ulcer at baseline. Erosive esophagitis or other endoscopic appearance that constitutes a risk to the subject, if included in the study, as judged by the investigator.
- Have positive test for Helicobacter pylori infection.
- Orthostatic hypotension with a systolic blood pressure drop of ≥ 25 mm Hg and/or a diastolic blood pressure drop of ≥ 15 mm Hg within 5 minutes of standing when changing from supine to erect position.
- A history of renal impairment, or a glomerular filtration rate (GFR) <60 mL/min or, at visit 1, a serum creatinine value >140 mol/L.
- Use of aspirin, H2 antagonists, antacids, misoprostol, proton pump inhibitors, sucralfate including two weeks prior to the screening visit.
- Patients currently taking sildenafil, anticoagulants or ticlopidine, nitrates, nitrovasodilating drugs (e.g. nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, glycerin trinitrate), diuretics (in a dose potentially leading to volume depletion).
- Use of analgesics in the 48 hrs preceding the day of dental surgery except use of acetaminophen until midnight on the day before surgery.
- Patients with oral surgery in the 30 days before the pre-study visit.
- Use of any prescribed medication during last two weeks or OTC medicinal products (including herbal preparations) during the last one week prior to initiation of study.
- History or presence of significant alcoholism or drug abuse in the past one year.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of smoking or use of other tobacco, pan, gutkha products since last 06 months.
- History or presence of significant asthma, urticaria or other allergic reactions.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- Difficulty in swallowing solids like tablets or capsules.
- History or presence of cancer.
- Difficulty with donating blood.
- Major illness during three months before screening.
- Participation in a drug research study within past three months.
- Donation of blood in the past three months before screening.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase I-Ib Study of P3914 to Evaluate the Safety, Tolerability, Food Effect & Pharmacokinetics in Healthy Male Subjects and Efficacy & Safety of P3914 in Patients With Acute Dental Pain
P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a NO moiety is intended for the treatment of pain and inflammation. The rationale behind development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory activity of naproxen and enhance GI safety by virtue of release of NO besides with no major effect on blood pressure on long-term administration.
- Conditions
- Acute Dental Pain
- Being tested
- P3914, Placebo
- Keywords
- Safety, Tolerability, Food Effect, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P3914Drug
Part A:
The subjects will be fasted overnight for at least 10 hrs.The drug will be administered orally to each subject in sitting posture.
Part B:
Dosing will start on Day 1. Each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14).
The investigational product will be administered orally to each subject with 240 mL of water.
Part C:
Dosing will take place on Day 1 of each study period. Each subject will receive a single oral dose.
For administration of P3914 tablets subjects will be required to fast for 10 hrs prior to dosing.
Part D:
Patients will be fasted for at least 4-6 hrs. The investigational product will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery).
PlaceboDrug
Part A:
The subjects will be fasted overnight for at least 10 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture.
Part B:
Dosing will start on Day 1. It is planned that each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14).
The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject with 240 mL of water.
Part D:
Patients will be fasted for at least 4-6 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery).
| Study group | Role | What they receive |
|---|---|---|
| P3914 | Experimental | Not described Receives: Drug: P3914 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs- systolic and diastolic blood pressure, pulse rate and oral body temperature.
Vital signs will be measured using DASH 4000. Predose vital signs will be recorded within 30 minutes prior to dosing.
Part A: pre-dose \& at 1,2,3,4,5,6,8,12,16,24,48,72,96 \& 120 hrs post dose. Part B:pre-dose on Day 2 to Day 13,predose \& at 4 and 12 hrs post-dose on Days 1 \&14.Part:C: pre-dose \& at 1, 2, 3, 4, 5,6,8,12,24,48,72,96 \& 120 hrs postdose.Part D:predose \& at 0.5,1,2,4,\&8 hrs post dose.
Measured: Defined in description
Secondary outcomes (5)
Pain intensity using 100 mm Visual analog scale
This assessment will be carried out in Part D of the study.
Measured: immediately before administration of study drug and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, and 8.00 hrs post-dose, and immediately before administration of rescue analgesia (if any).
Pharmacokinetic assessment for Part A
The concentration time data generated for P3914, naproxen and nitrate/nitrite levels will be used to calculate the following pharmacokinetic parameters as appropriate using non-compartmental analysis tool Tmax, Cmax, AUC0-t, AUC0-inf, AUC0-24h, % AUC Extrapolated, T1/2, kel, CL, Vz.
Measured: within 15 min prior to dosing. Post-dose blood samples will be drawn at 0.25, 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 & 120 hrs following drug administration.
Pharmacokinetic assessment for Part C
The concentration time data generated for P3914, Naproxen and nitrate/nitrite levels will be used to calculate the following pharmacokinetic parameters as appropriate using non-compartmental analysis tool:• Tmax, Cmax, AUC0-t, AUC0-inf, T1/2, and kel.
Measured: within 15 min prior to dosing. Post-dose samples will be drawn at 0.25, 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 6, 8, 10, 12, 24, 48, 72, 96 & 120 hrs following drug administration.
Pharmacokinetic assessment for Part B
The concentration time data generated for P3914, Naproxen and and nitrate/nitrite levels will be used to calculate the following pharmacokinetic parameters (as appropriate) using non-compartmental analysis tool:
Tmax, Cmax, AUC0-t, AUC0-inf, AUC0-24h, T1/2, kel, CL, Vz for Day 1 AND Cmax,ss, AUC0-τ,ss, Cmin,ss, Tmax,ss, Cavg,ss Swing, Percent Fluctuation, t1/2 and Kel for Day 14.
Measured: within 15 min prior to dosing on Day 1, 6, 9, 13&14. Post-dose blood samples at 0.25, 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 8, 10, 12, 16& 24 hrs following drug administration on Day 1 & Day 14 and 48 hrs post-dose on Day 16
Pharmacokinetic assessment for Part D
The concentration time data generated for P3914, Naproxen and nitrate/nitrite levels will be used to calculate the following pharmacokinetic parameters as appropriate using non-compartmental analysis tool:Tmax, Cmax, AUC0-t, AUC0-inf, T1/2, and kel.
Measured: within 15 min prior to dosing. Post-dose blood samples of at 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6 and 8 hrs following drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Dental 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Dharmesh Domadia, Principal investigator, Veeda Clinical research private limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339156
- Sponsor's protocol ID
- P3914/48/10
- Status last verified
- Nov 2012
- First submitted
- 15 Apr 2011
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase I-Ib Study of P3914 to Evaluate the Safety, Tolerability, Food Effect & Pharmacokinetics in Healthy Male Subjects and Efficacy & Safety of P3914 in Patients With Acute Dental Pain
- ClinicalTrials.gov ID
- NCT01339156
- Acronym / sponsor ID
- P3914/48/10
- Conditions
- Acute Dental Pain
- Keywords
- Safety, Tolerability, Food Effect, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Apr 2011 (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.
P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a NO moiety is intended for the treatment of pain and inflammation. The rationale behind development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory activity of naproxen and enhance GI safety by virtue of release of NO besides with no major effect on blood pressure on long-term administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P3914 | Experimental | Drug: P3914 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- for Part A, Part B and Part C
- Patients with acute postoperative dental pain (at least moderate in severity or score of 40 mm on VAS) after removal of an impacted third mandibular molar will be selected for study participation, if they meet the following criteria:
- Male patients aged between 18 and 60 years (including both).
- Patients with acute postoperative dental pain (at least moderate in severity or score of 40 mm on Visual Analogue Scale)
- Patients with otherwise normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
Key exclusion criteria (50 listed)
- Part A, Part B and Part C:
- Hypersensitivity to NSAIDs or nitrodonating drugs.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- History or presence of significant gastric and/or duodenal ulceration including the last three months or gastroduodenal bleeding including the last six months prior to the screening visit.
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 |
|---|---|---|
| P3914Part A: The subjects will be fasted overnight for at least 10 hrs.The drug will be administered orally to each subject in sitting posture. Part B: Dosing will start on Day 1. Each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14). The investigational product will be administered orally to each subject with 240 mL of water. Part C: Dosing will take place on Day 1 of each study period. Each subject will receive a single oral dose. For administration of P3914 tablets subjects will be required to fast for 10 hrs prior to dosing. Part D: Patients will be fasted for at least 4-6 hrs. The investigational product will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery). | Drug | P3914 |
| PlaceboPart A: The subjects will be fasted overnight for at least 10 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture. Part B: Dosing will start on Day 1. It is planned that each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14). The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject with 240 mL of water. Part D: Patients will be fasted for at least 4-6 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery). | Drug | Placebo |
Primary outcome
Vital signs- systolic and diastolic blood pressure, pulse rate and oral body temperature.
Time frame: Defined in description
Vital signs will be measured using DASH 4000. Predose vital signs will be recorded within 30 minutes prior to dosing. Part A: pre-dose \& at 1,2,3,4,5,6,8,12,16,24,48,72,96 \& 120 hrs post dose. Part B:pre-dose on Day 2 to Day 13,predose \& at 4 and 12 hrs post-dose on Days 1 \&14.Part:C: pre-dose \& at 1, 2, 3, 4, 5,6,8,12,24,48,72,96 \& 120 hrs postdose.Part D:predose \& at 0.5,1,2,4,\&8 hrs post dose.
5 secondary outcomes
Pain intensity using 100 mm Visual analog scale
Time frame: immediately before administration of study drug and at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, and 8.00 hrs post-dose, and immediately before administration of rescue analgesia (if any).
Pharmacokinetic assessment for Part A
Time frame: within 15 min prior to dosing. Post-dose blood samples will be drawn at 0.25, 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 & 120 hrs following drug administration.
Pharmacokinetic assessment for Part C
Time frame: within 15 min prior to dosing. Post-dose samples will be drawn at 0.25, 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 6, 8, 10, 12, 24, 48, 72, 96 & 120 hrs following drug administration.
Pharmacokinetic assessment for Part B
Time frame: within 15 min prior to dosing on Day 1, 6, 9, 13&14. Post-dose blood samples at 0.25, 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 8, 10, 12, 16& 24 hrs following drug administration on Day 1 & Day 14 and 48 hrs post-dose on Day 16
Pharmacokinetic assessment for Part D
Time frame: within 15 min prior to dosing. Post-dose blood samples of at 0.50, 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6 and 8 hrs following drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
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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.
Dr. Dharmesh Domadia principal investigator
Veeda Clinical research private limited
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P3914 in people with Acute Dental Pain, run by Piramal Enterprises Limited.
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 20 inclusion and 50 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: stopped early, as of the sponsor's last update on 22 Nov 2012. 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. 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 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.
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 was stopped early. Results are not available in the source record.
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?
Vital signs- systolic and diastolic blood pressure, pulse rate and oral body temperature. (time frame: Defined in description). 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 22 Nov 2012.