Duchenne Muscular Dystrophy (DMD)Phase 1ISOFEN1NCT01478022
To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20
A Phase 1 study testing Isosorbide Dinitrate, Ibuprofen and Ibuprofen and Isosorbide Dinitrate combination in people with Duchenne Muscular Dystrophy (DMD), run by Parent Project, Italy at 1 site in Italy.
Trial summary
This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose. This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for… Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Isosorbide Dinitrate, Ibuprofen and Ibuprofen and Isosorbide Dinitrate combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Mar 2016
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy free-living
- Males between the age of 18 and 27
- Normal ECG
- Body Mass Index of 19.0-29.0 (Kg/m2)
- Subject healthy in the opinion of the Investigator
- Signed informed consent after verbal and written information
Who cannot join
- Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
- Any Gastrointestinal conditions which, in the opinion of the Investigator, may interfere with the absorption of the drug or render the subjects unable to take oral medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhea, gastrointestinal surgery)
- History of the following cardiac diseases SBP <120 mmHG or DBP < 80 mmHg
- Platelet count < 100000/mm3
- History of recurrent headache
- History of ongoing or clinically relevant glaucoma
Show all 10Show fewer
- History of alcohol, drug or medication abuse within the past 2 years
- Treatment with norepinephrine, acetylcholine and histamine
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Participation in another study phase 1 with any investigational product within 6 months of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Randomized, 3 Period Cross-over Design, in Healthy Volunteers to Compare the Pharmacokinetics Profiles of 3 Treatments: ISO 20, IBU 200 and IBU Plus ISO Combinations (200 + 20) Administered Per os as Single Doses
This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose.
This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular dystrophy.
Read the detailed description
This trial is designed to define drug interactions following the combined administration of Isosorbide Dinitrate, a NO donor, and ibuprofen, NSAID, a through pharmacokinetics approach.
Both ibuprofen and Isosorbide Dinitrate were licensed worldwide. Ibuprofen is approved for use in adults and children; Isosorbide is approved for use in adults. Ibuprofen is currently used in pediatric patients as a first line anti-inflammatory and antipyretic agent. Consensus exists that among NSAIDs ibuprofen is the one endowed with less adverse effects (see note 66 of the Italian Drug Agency AIFA and MEA). No specific studies concerning safety and tolerability of ISDN in pediatric patients have been reported.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Isosorbide Dinitrate, Ibuprofen, Ibuprofen and Isosorbide Dinitrate combination
- Keywords
- DMD, Duchenne, Muscular Dystrophy
- Medical subject headings
- Muscular Dystrophy, Duchenne, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide DinitrateDrug
Also called Diniket 10 mg
Isosorbide Dinitrate 10 mgx2, daily, capsules
IbuprofenDrug
Also called Antalgil 200 mg
Ibuprofen 200 mg daily, capsules
Ibuprofen and Isosorbide Dinitrate combinationOther
Also called Antalgil 200 mg and Diniket 10 mg
Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose
| Study group | Role | What they receive |
|---|---|---|
| Isosorbide Dinitrate 20 mg | Active comparator | Isosorbide Dinitrate 10 mg b.i.d Receives: Drug: Isosorbide Dinitrate |
| Ibuprofen 200 mg | Active comparator | Ibuprofen 200 mg daily, capsule Receives: Drug: Ibuprofen |
| Isosorbide dinitrate and Ibuprofen | Experimental | Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily Receives: Other: Ibuprofen and Isosorbide Dinitrate combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: AUC 0-12
Area under the time-concentration curve (AUC 0-12) of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose
Measured: At period I, II and III with 7 days intervals between periods
Secondary outcomes (4)
C max
C max of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose
Measured: At period I, II and III with 7 days intervals between periods
T max
T max of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose
Measured: At period I, II and III with 7 days intervals beteween periods
Adverse Events
Adverse Events registration At visit 2, visit 3 and visit 4
Measured: 9 days
Vital signs
Pulse rate and blood pressure (Diastolic and Systolic) measurements in sitting position at pre-dose, and 1 and 3 hours after study drug intake. Complete physical examination At visit 2, visit 3 and visit 4
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parent Project, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilio Clementi, Principal investigator, Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478022
- Sponsor's protocol ID
- ISOFEN1
- Acronym
- ISOFEN1
- Status last verified
- Aug 2018
- First submitted
- 14 Nov 2011
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized, 3 Period Cross-over Design, in Healthy Volunteers to Compare the Pharmacokinetics Profiles of 3 Treatments: ISO 20, IBU 200 and IBU Plus ISO Combinations (200 + 20) Administered Per os as Single Doses
- ClinicalTrials.gov ID
- NCT01478022
- Acronym / sponsor ID
- ISOFEN1 / ISOFEN1
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- DMD, Duchenne, Muscular Dystrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Parent Project, ItalyUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Nov 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.
This study will evaluate the pharmacokinetics plasma profile of 3 treatments: ISO 20, IBU 200 and IBU and ISO combinations (200 +20) given in single dose.
This study is being conducted to support the submission for new indication in treatment of the combinations of Isosorbide Dinitrate and Ibuprofen as a treatment for Duchenne muscular dystrophy.
Detailed description
This trial is designed to define drug interactions following the combined administration of Isosorbide Dinitrate, a NO donor, and ibuprofen, NSAID, a through pharmacokinetics approach.
Both ibuprofen and Isosorbide Dinitrate were licensed worldwide. Ibuprofen is approved for use in adults and children; Isosorbide is approved for use in adults. Ibuprofen is currently used in pediatric patients as a first line anti-inflammatory and antipyretic agent. Consensus exists that among NSAIDs ibuprofen is the one endowed with less adverse effects (see note 66 of the Italian Drug Agency AIFA and MEA). No specific studies concerning safety and tolerability of ISDN in pediatric patients have been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isosorbide Dinitrate 20 mg | Active comparator | Drug: Isosorbide DinitrateIsosorbide Dinitrate 10 mg b.i.d |
| Ibuprofen 200 mg | Active comparator | Drug: IbuprofenIbuprofen 200 mg daily, capsule |
| Isosorbide dinitrate and Ibuprofen | Experimental | Other: Ibuprofen and Isosorbide Dinitrate combinationIsosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy free-living
- Males between the age of 18 and 27
- Normal ECG
- Body Mass Index of 19.0-29.0 (Kg/m2)
- Subject healthy in the opinion of the Investigator
Key exclusion criteria (10 listed)
- Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
- Any Gastrointestinal conditions which, in the opinion of the Investigator, may interfere with the absorption of the drug or render the subjects unable to take oral medication (gastric ulcer, peptic ulcer, stomach acid, frequent diarrhea, gastrointestinal surgery)
- History of the following cardiac diseases SBP <120 mmHG or DBP < 80 mmHg
- Platelet count < 100000/mm3
- History of recurrent headache
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 |
|---|---|---|
| Isosorbide DinitrateAlso: Diniket 10 mgIsosorbide Dinitrate 10 mgx2, daily, capsules | Drug | Isosorbide Dinitrate 20 mg |
| IbuprofenAlso: Antalgil 200 mgIbuprofen 200 mg daily, capsules | Drug | Ibuprofen 200 mg |
| Ibuprofen and Isosorbide Dinitrate combinationAlso: Antalgil 200 mg and Diniket 10 mgIbuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose | Other | Isosorbide dinitrate and Ibuprofen |
Primary outcome
Pharmacokinetic parameter: AUC 0-12
Time frame: At period I, II and III with 7 days intervals between periods
Area under the time-concentration curve (AUC 0-12) of IBU and ISO given concomitantly compared to AUCs of ISO alone and IBU alone. Time points: = at pre dose, 30, 60, 90, 120, 150, 180, 210, 240 min and 5, 6, 8, 10 and 12 hrs post dose
4 secondary outcomes
C max
Time frame: At period I, II and III with 7 days intervals between periods
T max
Time frame: At period I, II and III with 7 days intervals beteween periods
Adverse Events
Time frame: 9 days
Vital signs
Time frame: 9 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 31 Aug 2018.
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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.
Emilio Clementi principal investigator
Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano
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 Isosorbide Dinitrate, Ibuprofen and Ibuprofen and Isosorbide Dinitrate combination in people with Duchenne Muscular Dystrophy (DMD), run by Parent Project, Italy at 1 site in Italy.
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 6 inclusion and 10 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 31 Aug 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 Italy. 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?
Pharmacokinetic parameter: AUC 0-12 (time frame: At period I, II and III with 7 days intervals between periods). 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 31 Aug 2018.