Gastroduodenal ErosionsPhase 1NCT02521207
Pilot Study of OXP001(2) and Brufen in Healthy Subjects
A Phase 1 study testing Ibuprofen in people with Gastroduodenal Erosions, run by Oxford Pharmascience Ltd at 1 site in United Kingdom.
Trial summary
The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroduodenal Erosions
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Sep 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subject
- Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) (Part 2 only)
- H. pylori negative
Who cannot join
- Clinically significant abnormal laboratory parameters
- Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, GI or any other body system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study With OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Healthy Human Subjects
The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.
The study will consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.
- Conditions
- Gastroduodenal Erosions
- Being tested
- Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 OXP001 | Experimental | OXP001 formulation containing 800mg ibuprofen single dose Receives: Drug: Ibuprofen |
| Part 1 Ibuprofen control | Active comparator | Ibuprofen control 800mg single dose Receives: Drug: Ibuprofen |
| Part 2 OXP001 | Experimental | OXP001 formulation containing 800mg ibuprofen three times per day Receives: Drug: Ibuprofen |
| Part 2 Ibuprofen control | Experimental | Ibuprofen control 800mg three times per day Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Comparison of Peak Plasma Concentration (Cmax)
Measured: Part 1; Day 1 and Day 4
Part 2: Comparison of Average Lanza Score
Measured: Part 2; Day 8
Part 2: Comparison of Average Number of Erosions
Measured: Day 8
Part 1: Comparison of Area Under the Curve (AUC)
Measured: Part 1; Day 1 and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroduodenal ErosionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Pharmascience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, Principal investigator, Quotient Clinical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521207
- Sponsor's protocol ID
- OXP001-003
- Status last verified
- Oct 2015
- First submitted
- 5 Aug 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study With OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT02521207
- Acronym / sponsor ID
- OXP001-003
- Conditions
- Gastroduodenal Erosions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Oxford Pharmascience LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Aug 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 study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.
The study will consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 OXP001 | Experimental | Drug: IbuprofenOXP001 formulation containing 800mg ibuprofen single dose |
| Part 1 Ibuprofen control | Active comparator | Drug: IbuprofenIbuprofen control 800mg single dose |
| Part 2 OXP001 | Experimental | Drug: IbuprofenOXP001 formulation containing 800mg ibuprofen three times per day |
| Part 2 Ibuprofen control | Experimental | Drug: IbuprofenIbuprofen control 800mg three times per day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subject
- Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) (Part 2 only)
- H. pylori negative
Key exclusion criteria (2 listed)
- Clinically significant abnormal laboratory parameters
- Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, GI or any other body system
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 | Part 1 Ibuprofen control, Part 1 OXP001, Part 2 Ibuprofen control, Part 2 OXP001 |
Primary outcome
Part 1: Comparison of Peak Plasma Concentration (Cmax)
Time frame: Part 1; Day 1 and Day 4
Part 2: Comparison of Average Lanza Score
Time frame: Part 2; Day 8
Part 2: Comparison of Average Number of Erosions
Time frame: Day 8
Part 1: Comparison of Area Under the Curve (AUC)
Time frame: Part 1; Day 1 and Day 4
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 28 Oct 2015.
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.
Stuart Mair principal investigator
Quotient Clinical Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen in people with Gastroduodenal Erosions, run by Oxford Pharmascience Ltd 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 3 inclusion and 2 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 28 Oct 2015. 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.
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 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?
Part 1: Comparison of Peak Plasma Concentration (Cmax) (time frame: Part 1; Day 1 and Day 4). The study lists 4 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 28 Oct 2015.