Carol Conrad
Mpex 204 Phase 2
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of MP-376 solution (study drug) delivered by the PARI eFlow electronioc nebulizer to stable cystic fibrosis (CF) patients.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: MP-376
Phase:
Phase 2Eligibility
Ages Eligible for Study:
16 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Cystic fibrosis patients will be included in the study if they meet all of the following criteria:
1. Are at least 16 years of age (at least 18 years of age in Germany and the Netherlands).
2. Have a clinical diagnosis of CF based on the following criteria:
a) positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or
b) a genotype with two identifiable mutations consistent with CF, and
c) accompanied by one or more clinical features consistent with the CF phenotype.
3. Are able to elicit an FEV1 > 25% but < 85% predicted value at screening based on Hankinson/NHanes criteria
4. Have received at least 3 courses inhaled antimicrobials over the preceding 12 months and have received at least one course of inhaled tobramycin/TOBI in the 2 months prior to Visit 1, but none in the 30 days prior to Visit 1.
5. Must have a sputum specimen at screening positive for P. aeruginosa and have a history of at least one positive sputum culture positive for P. aeruginosa within the last 18 months.
6. Clinically stable with no significant changes in health status within the last 30 days.
7. Are able to perform spirometry reproducibly.
8. Have not smoked tobacco within 30 days prior to Visit 1 and agree not to smoke for the duration of the study.
9. Are able to reproducibly expectorate sputum.
10. Are able to and have given written informed assent/consent in a manner approved by the Institutional Review Board/Ethics Committee, and are willing to comply with the requirements of the study.
Key Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
1. Have used an investigational agent within 30 days prior to Visit 1.
2. Have used any nebulized or systemic antibiotics active against P. aeruginosa within 30 days prior to Visit 1, other than maintenance oral azithromycin, which must be have been initiated at least 30 days prior to Visit 1.
3. History of hypersensitivity to fluoroquinolones or any excipients of MP-376 (magnesium chloride).
4. Previous patients enrolled in the Phase I studies who have received MP-376.
5. Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
6. Changes in physiotherapy technique or schedule within 14 days prior to Visit 1.
7. Changes in medical regimen for treatment of CF (e.g., introduction, dose escalation, or elimination of therapies such as dornase alfa, non-steroidal anti-inflammatory agents, azithromycin, hypertonic saline, or inhaled corticosteroids) within 30 days of Visit 1.
8. History of solid organ transplantation.
9. Evidence of acute upper within 10 days or lower respiratory tract infection within 30 days prior to Visit 1.
10. Are pregnant, breastfeeding, or unwilling to practice birth control or abstinence during participation in the study (women only).
11. Have a history of seizures or low seizure threshold (e.g., epilepsy).
12. Have renal dysfunction (calculated CrCl < 50mg/ml) at screening.
13. Have AST, ALT or total bilirubin > 3 x upper limit of normal (ULN) at screening or evidence of severe liver disease (e.g., cirrhosis, portal hypertension).
14. Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection/seropositivity.*
15. Have a history of hemoptysis > 30 mLs over any 24 hour period during the 30 days prior to Visit 1.
16. Have an oxygen saturation < 90% on room air at Screening or Visit 1.
17. Have a > 15% relative decline in FEV1(L) from Screening to Visit 1.
18. Are a dependent (as an employee or relative) of the sponsor, contract research organization or investigator.
19. Have a present condition, or abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.
* Based on medical history, screening labs are not required
Additional Study Details
Official Title:
A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF THREE DOSAGE REGIMENS OF MP-376 SOLUTION FOR INHALATION GIVEN FOR 28 DAYS TO STABLE CYSTIC FIBROSIS PATIENTSAnticipated start date:
7/16/2008Lead Sponsor:
Mpex PharmaceuticalsInvestigator(s):
- Carol K. Conrad
- Richard B Moss
- Paul K Mohabir
- Carlos Milla
- Terry Earl Robinson
- Zoe Davies RN
- Colleen Dunn RCP
- Martha Hamilton
- Yan Ki Angela Leung
- Daisy Carolina Diaz
Study Type:
InterventionalPurpose:
UnspecifiedAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- The primary efficacy endpoint to be assessed in this Phase 2 study will be microbiological (change in bacterial counts in sputum).
Secondary Outcomes:
- Other efficacy endpoints including clinical endpoints (CFQ-R), pulmonary function tests (FEV1), PK evaluations, additional microbiology (total bacterial load and susceptibility patterns) will be assessed as change from Visit 1 to all subsequent visits where the endpoint is collected.
Total Number to be Enrolled:
140Total Number to be Enrolled at Stanford:
4More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/3/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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