HealthyNCT03658720
Nurofen Ibuprofen Orodispersible Tablet Disintegration Study
A study testing 200 mg Ibuprofen acid orodispersible tablet in people with Healthy, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
Trial summary
Disintegration time is an important quality attribute of ODTs, and the evaluation of disintegration time is positioned as a key step in formulation development, manufacturing, and clinical practice. The standard recommended over-the counter dose of 200mg Nurofen ibuprofen ODT is one (200mg) to two (400mg) tablets. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 200 mg Ibuprofen acid orodispersible tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2017to 21 Dec 2017
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects who have given written informed consent.
- Age: ≥ 18 years ≤ 50 years.
- Body Mass Index (BMI) of ≥ 18.5 and ≤ 30 kg/m2.
- Healthy as determined by past medical history, physical examination and vital signs at screening.
Who cannot join
- A history of allergy or intolerance (including angioedema, urticaria, bronchospasm, reflux symptoms and rhinitis) related to treatment with ibuprofen, aspirin or other NSAIDs, or the excipients of the formulations.
- A history (treated or untreated) of an oral condition affecting salivation and mouth dryness (e.g. dry mouth, hypersalivation)
- A history of hepatic or renal impairment, hepatic dysfunction, cardiovascular disease, cerebrovascular problems or high blood pressure.
- A history of asthma.
- A history of peptic or duodenal ulcers or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders (including gastro-oesophageal reflux symptoms or gastritis) ulceration, perforation or haemorrhage.
- A history of coagulation disorder or susceptibility to bleeding
Show all 27Show fewer
- A current or recent (within 2 months) oral issue, which in the opinion of the Principal Investigator could interfere with the study (e.g. mouth ulcers, aphthous ulcers, herpetic disease, oral candidiasis, burning mouth syndrome, geographic tongue, oral swellings, sores or lesions.
- Those currently suffering from dehydration
- A current or history of oral piercing.
- A current or recent history (within one year of the study) of alcohol abuse or significant abuse/misuse of any legal or illegal drugs, substances and solvents
- Those with a positive screen/test for drugs of abuse and/or alcohol
- Those who consume more than 14 units of alcohol per week, and where this consumption is spread over less than 3 days, or those who regularly (weekly) consumed excessive amounts of alcohol (>8 units for men and >6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics)
- Those who had consumed alcohol within the 24 hours before enrolment onto the study.
- Those who had regularly consumed excessive quantities of caffeine (>6 cups of tea, coffee or cola per day), according to the Investigator's judgment.
- Those who had consumed caffeine-containing food and drinks within the 24 hours before enrolment onto the study.
- Those who had performed strenuous exercise within the 24 hours before enrolment onto the study.
- Those who currently or have recently (within last 6 months) use/d tobacco or nicotine containing products.
- Those who have used any herbal/vitamin or fish oil supplement in the 7 days prior to enrolment
- Those who have used any OTC or prescription medications (except hormonal contraceptives) in the 7 days prior to enrolment
- Those who have used ibuprofen with concomitant aspirin or other NSAIDs including cyclooxygenase-2 selective inhibitors and any drugs that should be used with caution, in combination with ibuprofen as per the SmPC, in the 7 days prior to enrolment (or longer if stated within the SmPC)
- Those previously randomised into this study.
- Those who are an employee at the study site.
- Those who are a partner or first-degree relative of the Investigator or other employees.
- Those who have participated in any taste testing study within 3 days of the screening visit.
- Those who have participated in a clinical trial involving consumption of an investigational medicinal product within 3 months of dosing or a study with a marketed compound in the last month before dosing.
- Those unable in the opinion of the Investigator to comply fully with the study requirements.
- Women who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Open Label, Single Dose, 2-way Crossover Study to Evaluate Oral Disintegration Time of a Single Nurofen Ibuprofen Orodispersible Tablet (ODT) and Two Nurofen Ibuprofen ODTs (200mg Ibuprofen Acid), in Fasted Healthy Volunteers
Disintegration time is an important quality attribute of ODTs, and the evaluation of disintegration time is positioned as a key step in formulation development, manufacturing, and clinical practice. The standard recommended over-the counter dose of 200mg Nurofen ibuprofen ODT is one (200mg) to two (400mg) tablets. To reflect this, the disintegration time of both one (200mg) and two (400mg) tablets will be assessed in this study.
Studies have been performed assessing in vivo ODT disintegration time and have created standardised oral conditions by giving water prior to dosing, to moisten/wet the mouth. In this study it is therefore necessary to standardise the oral conditions as much as possible, despite the interpersonal variability, to measure the time it takes for the ODT to disintegrate. For this study, 20 mL of water is swallowed prior to dosing to standardise oral conditions. Thirty-three healthy volunteers are required to be randomised into the study, to allow evaluable data to be obtained for 30 subjects. Subjects are given a light meal/snack and then fast for 2 hours 15 minutes (± 15 minutes) before dosing, in order to bring the oral cavity environment as close as possible to standard levels and to minimise variability in salivation. Directly before dosing, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects are dosed according to the sequence they have been randomised and the ODT disintegration time assessed.
Read more
Following the first dose, subjects complete a washout period of a minimum of 4 hours, in accordance with the recommended posology, before receiving the second dose. During this washout period, subjects are given a second light meal/snack (the same as the previous light meal/snack), timed to allow subjects to fast for 2 hours 15 minutes (± 15 minutes) before the second dose. Directly before the second dose, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects then receive the alternative dose to the dose they received during the first assessment, in accordance with the randomisation sequence.
Following completion of the disintegration assessments, or upon subject withdrawal, subjects are asked whether they are experiencing any symptoms or complaints. Any AEs are recorded in the CRF and followed up as necessary by the Investigator. Subjects then leave the clinic.Subjects are contacted by the Investigator (or designee) from 24 to up to 48 hours to ensure any AEs are captured.
- Conditions
- Healthy
- Being tested
- 200 mg Ibuprofen acid orodispersible tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg Ibuprofen acid orodispersible tabletDrug
Also called Meltlet, Nurofen
orodispersible tablet
| Study group | Role | What they receive |
|---|---|---|
| Single tablet | Experimental | Ibuprofen acid ODT: 1x200mg dose. Administered without water after the subject has swallowed (with oral cavity rinsing) 20 mL of water. This was following a fasting period of 2 hours 15 minutes (± 15 minutes). The fasting period started after the subject consumed a standardised light meal/snack. Receives: Drug: 200 mg Ibuprofen acid orodispersible tablet |
| Two tablets | Experimental | Ibuprofen acid ODTs: 2x200mg dose. Administered without water after the subject has swallowed (with oral cavity rinsing) 20 mL of water. This was following a fasting period of 2 hours 15 minutes (± 15 minutes). The fasting period started after the subject consumed a standardised light meal/snack. Receives: Drug: 200 mg Ibuprofen acid orodispersible tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tablet disintegration time
Time to complete tablet disintegration in seconds
Measured: Time of dosing to complete disintegration of the tablet being achieved (2 doses; single assessment day)
Secondary outcomes (1)
Number of Adverse Events
Measured: Up to follow up (24-48 hours after assessment day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start19 Dec 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Why it stopped: Study was not feasible as designed to allow for appropriate completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Clinical Research Director, Clinical Research, Study director, Reckitt Benckiser Healthcare (UK) Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658720
- Sponsor's protocol ID
- 0414106
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Open Label, Single Dose, 2-way Crossover Study to Evaluate Oral Disintegration Time of a Single Nurofen Ibuprofen Orodispersible Tablet (ODT) and Two Nurofen Ibuprofen ODTs (200mg Ibuprofen Acid), in Fasted Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03658720
- Acronym / sponsor ID
- 0414106
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was not feasible as designed to allow for appropriate completion
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 5 Sep 2018 (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.
Disintegration time is an important quality attribute of ODTs, and the evaluation of disintegration time is positioned as a key step in formulation development, manufacturing, and clinical practice. The standard recommended over-the counter dose of 200mg Nurofen ibuprofen ODT is one (200mg) to two (400mg) tablets. To reflect this, the disintegration time of both one (200mg) and two (400mg) tablets will be assessed in this study.
Studies have been performed assessing in vivo ODT disintegration time and have created standardised oral conditions by giving water prior to dosing, to moisten/wet the mouth. In this study it is therefore necessary to standardise the oral conditions as much as possible, despite the interpersonal variability, to measure the time it takes for the ODT to disintegrate. For this study, 20 mL of water is swallowed prior to dosing to standardise oral conditions. Thirty-three healthy volunteers are required to be randomised into the study, to allow evaluable data to be obtained for 30 subjects. Subjects are given a light meal/snack and then fast for 2 hours 15 minutes (± 15 minutes) before dosing, in order to bring the oral cavity environment as close as possible to standard levels and to minimise variability in salivation. Directly before dosing, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects are dosed according to the sequence they have been randomised and the ODT disintegration time assessed.
Following the first dose, subjects complete a washout period of a minimum of 4 hours, in accordance with the recommended posology, before receiving the second dose. During this washout period, subjects are given a second light meal/snack (the same as the previous light meal/snack), timed to allow subjects to fast for 2 hours 15 minutes (± 15 minutes) before the second dose. Directly before the second dose, subjects drink (with oral cavity rinsing) 20 mL of water. Subjects then receive the alternative dose to the dose they received during the first assessment, in accordance with the randomisation sequence.
Following completion of the disintegration assessments, or upon subject withdrawal, subjects are asked whether they are experiencing any symptoms or complaints. Any AEs are recorded in the CRF and followed up as necessary by the Investigator. Subjects then leave the clinic.Subjects are contacted by the Investigator (or designee) from 24 to up to 48 hours to ensure any AEs are captured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single tablet | Experimental | Drug: 200 mg Ibuprofen acid orodispersible tabletIbuprofen acid ODT: 1x200mg dose. Administered without water after the subject has swallowed (with oral cavity rinsing) 20 mL of water. This was following a fasting period of 2 hours 15 minutes (± 15 minutes). The fasting period started after the subject consumed a standardised light meal/snack. |
| Two tablets | Experimental | Drug: 200 mg Ibuprofen acid orodispersible tabletIbuprofen acid ODTs: 2x200mg dose. Administered without water after the subject has swallowed (with oral cavity rinsing) 20 mL of water. This was following a fasting period of 2 hours 15 minutes (± 15 minutes). The fasting period started after the subject consumed a standardised light meal/snack. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female subjects who have given written informed consent.
- Age: ≥ 18 years ≤ 50 years.
- Body Mass Index (BMI) of ≥ 18.5 and ≤ 30 kg/m2.
- Healthy as determined by past medical history, physical examination and vital signs at screening.
Key exclusion criteria (27 listed)
- A history of allergy or intolerance (including angioedema, urticaria, bronchospasm, reflux symptoms and rhinitis) related to treatment with ibuprofen, aspirin or other NSAIDs, or the excipients of the formulations.
- A history (treated or untreated) of an oral condition affecting salivation and mouth dryness (e.g. dry mouth, hypersalivation)
- A history of hepatic or renal impairment, hepatic dysfunction, cardiovascular disease, cerebrovascular problems or high blood pressure.
- A history of asthma.
- A history of peptic or duodenal ulcers or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders (including gastro-oesophageal reflux symptoms or gastritis) ulceration, perforation or haemorrhage.
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 |
|---|---|---|
| 200 mg Ibuprofen acid orodispersible tabletAlso: Meltlet, Nurofenorodispersible tablet | Drug | Single tablet, Two tablets |
Primary outcome
Tablet disintegration time
Time frame: Time of dosing to complete disintegration of the tablet being achieved (2 doses; single assessment day)
Time to complete tablet disintegration in seconds
1 secondary outcome
Number of Adverse Events
Time frame: Up to follow up (24-48 hours after assessment day)
Results and safety
The study was stopped early (reason given: Study was not feasible as designed to allow for appropriate completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- 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.
Clinical Research Director, Clinical Research study director
Reckitt Benckiser Healthcare (UK) Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 200 mg Ibuprofen acid orodispersible tablet in people with Healthy, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United Kingdom.
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 27 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 5 Sep 2018. 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 United Kingdom. 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.
Are results available for this study?
The study was stopped early (reason given: Study was not feasible as designed to allow for appropriate completion). 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?
Tablet disintegration time (time frame: Time of dosing to complete disintegration of the tablet being achieved (2 doses; single assessment day)). 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 5 Sep 2018.