NCT01478022

Brief 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 Duchenne muscular dystrophy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4.4 years

First QC Date

November 14, 2011

Last Update Submit

August 29, 2018

Conditions

Duchenne Muscular Dystrophy (DMD)

Keywords

DMDDuchenneMuscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • 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

    At period I, II and III with 7 days intervals between periods

Secondary Outcomes (4)

  • C max

    At period I, II and III with 7 days intervals between periods

  • T max

    At period I, II and III with 7 days intervals beteween periods

  • Adverse Events

    9 days

  • Vital signs

    9 days

Study Arms (3)

Isosorbide Dinitrate 20 mg

ACTIVE COMPARATOR

Isosorbide Dinitrate 10 mg b.i.d

Drug: Isosorbide Dinitrate

Ibuprofen 200 mg

ACTIVE COMPARATOR

Ibuprofen 200 mg daily, capsule

Drug: Ibuprofen

Isosorbide dinitrate and Ibuprofen

EXPERIMENTAL

Isosorbide dinitrate 20 mg daily and Ibuprofen 200 mg daily

Other: Ibuprofen and Isosorbide Dinitrate combination

Interventions

Isosorbide DinitrateDRUG

Isosorbide Dinitrate 10 mgx2, daily, capsules

Also known as: Diniket 10 mg
Isosorbide Dinitrate 20 mg
IbuprofenDRUG

Ibuprofen 200 mg daily, capsules

Also known as: Antalgil 200 mg
Ibuprofen 200 mg
Ibuprofen and Isosorbide Dinitrate combinationOTHER

Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose

Also known as: Antalgil 200 mg and Diniket 10 mg
Isosorbide dinitrate and Ibuprofen

Eligibility Criteria

Age18 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Phase 1 Unit - Luigi Sacco Hospital

Milan, 20157, Italy

Location

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMuscular Dystrophies

Interventions

Isosorbide DinitrateIbuprofen

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

IsosorbideSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Emilio Clementi

    Luigi Sacco Hospital - Phase I Department - Via G. B. Grassi 74 20157 Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 23, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

IT(1)