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Trial record 25 of 507 for:    MOXIFLOXACIN

QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo

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ClinicalTrials.gov Identifier: NCT01191723
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : October 22, 2013
Last Update Posted : January 9, 2014
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: MAP0004
Drug: Inhaler Placebo
Drug: Moxifloxacin
Drug: Placebo Capsule
Enrollment 54
Recruitment Details  
Pre-assignment Details This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
Arm/Group Title Treatment A, Then B, Then C Treatment A, Then C, Then B Treatment B, Then A, Then C Treatment B, Then C, Then A Treatment C, Then A, Then B Treatment C, Then B, Then A
Hide Arm/Group Description

Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4.

Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.

Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.

Treatment C = inhaler placebo and placebo capsules at Visit 4.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.

Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.

Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4.

Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Period Title: Overall Study
Started 9 9 9 9 9 9
Completed 9 9 9 9 9 9
Not Completed 0 0 0 0 0 0
Arm/Group Title All Subjects
Hide Arm/Group Description All subjects enrolled in the study.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
28.0  (6.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
34
  63.0%
Male
20
  37.0%
1.Primary Outcome
Title Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes
Hide Description The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Time Frame baseline and 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available at required time point were included in the analysis population.
Arm/Group Title Treatment C (Placebo) Treatment B (MAP0004 3.0mg)
Hide Arm/Group Description:
Treatment C = inhaler placebo and placebo capsules.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
Overall Number of Participants Analyzed 52 54
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 408.8  (20.1) 409.6  (20.9)
Change from Baseline at 30 mins -4.7  (6.2) -4.6  (7.3)
2.Primary Outcome
Title Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Hide Description The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Time Frame baseline and 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available at required time point were included in the analysis population.
Arm/Group Title Treatment C (Placebo) Treatment B (MAP0004 3.0mg) Treatment A (Moxifloxacin)
Hide Arm/Group Description:
Treatment C = inhaler placebo and placebo capsules at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
Overall Number of Participants Analyzed 52 54 54
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 408.8  (20.1) 409.6  (20.9) 408.6  (20.0)
Change from Baseline at 2 hours -2.3  (7.0) -5.1  (6.7) 9.0  (6.8)
3.Secondary Outcome
Title Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes
Hide Description The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Time Frame baseline and 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available at required time point were included in the analysis population.
Arm/Group Title Treatment C (Placebo) Treatment B (MAP0004 3.0mg)
Hide Arm/Group Description:
Treatment C = inhaler placebo and placebo capsules.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
Overall Number of Participants Analyzed 52 54
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 406.8  (18.4) 407.7  (20.0)
Change from Baseline at 30 mins -5.0  (6.4) -4.7  (6.7)
4.Secondary Outcome
Title Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
Hide Description The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Time Frame baseline and 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available at required time point were included in the analysis population.
Arm/Group Title Treatment C (Placebo) Treatment B (MAP0004 3.0mg) Treatment A (Moxifloxacin)
Hide Arm/Group Description:
Treatment C = inhaler placebo and placebo capsules at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
Overall Number of Participants Analyzed 52 54 54
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 406.8  (18.4) 407.7  (20.0) 407.0  (18.7)
Change from Baseline at 2 hours -1.8  (6.9) -3.9  (6.0) 8.5  (6.3)
5.Secondary Outcome
Title Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours
Hide Description The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.
Time Frame baseline, 30 minutes, and 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data available at required time point were included in the analysis population.
Arm/Group Title Treatment C (Placebo) Treatment B (MAP0004 3.0mg) Treatment A (Moxifloxacin)
Hide Arm/Group Description:
Treatment C = inhaler placebo and placebo capsules at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
Overall Number of Participants Analyzed 52 54 54
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Baseline 64.1  (9.1) 64.6  (9.5) 63.8  (9.5)
Change from Baseline at 30 minutes 1.0  (4.2) -0.2  (5.8) 2.4  (4.1)
Change from Baseline at 2 hours -2.1  (4.3) -4.4  (6.7) 0.3  (5.2)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
 
Arm/Group Title Treatment C (Placebo) Treatment B (MAP0004 3.0mg) Treatment A (Moxifloxacin)
Hide Arm/Group Description Treatment C = inhaler placebo and placebo capsules Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet
All-Cause Mortality
Treatment C (Placebo) Treatment B (MAP0004 3.0mg) Treatment A (Moxifloxacin)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment C (Placebo) Treatment B (MAP0004 3.0mg) Treatment A (Moxifloxacin)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/54 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment C (Placebo) Treatment B (MAP0004 3.0mg) Treatment A (Moxifloxacin)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/54 (3.70%)   26/54 (48.15%)   8/54 (14.81%) 
Gastrointestinal disorders       
Nausea  1  0/54 (0.00%)  15/54 (27.78%)  2/54 (3.70%) 
Vomiting  1  0/54 (0.00%)  4/54 (7.41%)  0/54 (0.00%) 
Nervous system disorders       
Dizziness  1  0/54 (0.00%)  5/54 (9.26%)  4/54 (7.41%) 
Headache  1  2/54 (3.70%)  10/54 (18.52%)  2/54 (3.70%) 
Paraesthesia  1  0/54 (0.00%)  3/54 (5.56%)  0/54 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP, Scientific Affairs
Organization: MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan
Phone: 650-386-3100
EMail: dkellerman@mappharma.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01191723     History of Changes
Other Study ID Numbers: MAP0004-CL-P103
First Submitted: August 27, 2010
First Posted: August 31, 2010
Results First Submitted: August 19, 2013
Results First Posted: October 22, 2013
Last Update Posted: January 9, 2014