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Trial record 87 of 419 for:    TRANEXAMIC ACID

Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding (PREA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01190150
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : July 3, 2012
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Menorrhagia
Intervention Drug: tranexamic acid
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.65 g / 1.3 g Tranexamic Acid 1.3 g / 0.65 g Tranexamic Acid
Hide Arm/Group Description Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8. Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
Period Title: First Treatment
Started 11 [1] 9 [1]
Completed 10 9
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
[1]
Randomized, as well as Safety and PK populations
Period Title: Washout
Started 10 9
Completed 10 7
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Difficulty in adherence             0             1
Period Title: Second Treatment
Started 10 7
Completed 10 7
Not Completed 0 0
Arm/Group Title 0.65 g / 1.3 g Tranexamic Acid 1.3 g / 0.65 g Tranexamic Acid Total
Hide Arm/Group Description Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8. Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8. Total of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 20 participants
14.5  (1.13) 14.3  (1.32) 14.4  (1.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
11
 100.0%
9
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  11.1%
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  63.6%
6
  66.7%
13
  65.0%
White
4
  36.4%
2
  22.2%
6
  30.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Maximum Concentrations Level (Cmax)
Hide Description Cmax is the maximum measured plasma concentration over the time-span specified.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population includes all participants with at least one quantifiable PK concentration.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: μg/mL
6.9967  (2.08058) 10.9868  (3.38910)
2.Primary Outcome
Title Dose-normalized Maximum Concentrations Level (Cmax)
Hide Description Cmax is the maximum measured plasma concentration over the time-span specified and normalized to the 1.3 g dose.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population includes all participants with at least one quantifiable PK concentration.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: μg/mL
13.9933  (4.16115) 10.9868  (3.38910)
3.Primary Outcome
Title Time to Maximum Concentration Level (Tmax)
Hide Description Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population includes all participants with at least one quantifiable PK concentration.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: hours
3.17  (0.642) 3.11  (0.679)
4.Primary Outcome
Title Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)
Hide Description The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population includes all participants with at least one quantifiable PK concentration.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
38.8067  (10.56742) 56.7935  (19.27448)
5.Primary Outcome
Title Dose Normalized Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)
Hide Description The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration normalized to the 1.3 g dose.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population includes all participants with at least one quantifiable PK concentration.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
77.6134  (21.13483) 56.7935  (19.27448)
6.Primary Outcome
Title Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)
Hide Description The area under the plasma concentration versus time curve from time 0 to infinity. AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
39.8016  (10.71237) 61.2591  (15.45770)
7.Primary Outcome
Title Dose Normalized Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)
Hide Description Dose-normalized AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, normalized to the 1.3 g dose.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: μg*h/mL
79.6032  (21.42474) 61.2591  (15.45770)
8.Primary Outcome
Title The Ratio of AUC0-t to AUCinf
Hide Description Comparison of AUC0-t to AUCinf by creating a ratio.
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ratio of AUC0-t / AUCinf
0.9741  (0.00862) 0.9715  (0.01158)
9.Primary Outcome
Title Elimination Half-life (t ½)
Hide Description Apparent first-order terminal elimination half life
Time Frame Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma PK population includes all participants with at least one quantifiable PK concentration.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: hours
5.06  (1.194) 5.42  (1.463)
10.Secondary Outcome
Title Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description Treatment-emergent AEs are summarized by total participants with TEAEs, participants with serious TEAEs, participants with TEAEs deemed by the investigator to be related to treatment, and participants who experienced TEAEs that caused permanent discontinuation from the study.
Time Frame Day 1 up to week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of all randomized participants who received at least one dose of tranexamic acid.
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description:
Participants were treated with a single dose of 0.65 g tranexamic acid.
Participants were treated with a single dose of 1.3 g tranexamic acid.
Overall Number of Participants Analyzed 18 19
Measure Type: Number
Unit of Measure: participants
Participants with TEAEs 1 2
Participants with serious TEAEs 0 0
Participants with treatment-related TEAEs 0 1
Participants with TEAEs causing discontinuation 0 0
Time Frame Day 1 up to week 4
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Hide Arm/Group Description Participants were treated with a single dose of 0.65 g tranexamic acid. Participants were treated with a single dose of 1.3 g tranexamic acid.
All-Cause Mortality
0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0.65 g Tranexamic Acid 1.3 g Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   2/19 (10.53%) 
Nervous system disorders     
Dizziness  1  0/18 (0.00%)  2/19 (10.53%) 
Headache  1  0/18 (0.00%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders     
Blister  1  1/18 (5.56%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
EMail: DK0-Disclosure@ferring.com
Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01190150     History of Changes
Other Study ID Numbers: FE999304 CS01
First Submitted: August 26, 2010
First Posted: August 27, 2010
Results First Submitted: May 30, 2012
Results First Posted: July 3, 2012
Last Update Posted: July 16, 2012