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TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine

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ClinicalTrials.gov Identifier: NCT00385008
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: Combination Product (sumatriptan succinate / naproxen sodium)
Drug: RELPAX(eletriptan) 40mg Tablet
Enrollment 20

Recruitment Details This study was conducted at a single site in the United States during 13 September 2006 to 24 November 2006. TREXIMA® tablet was a fixed dose combination of sumatriptan succinate 119 milligrams (mg) (equivalent to 85 mg of sumatriptan) and naproxen sodium 500 mg.
Pre-assignment Details First ten participants enrolled received TREXIMA and the next ten enrolled received Relpax. In each group, the first 5 participants who had a migraine and who were able to attend the clinic received the extra dose of the respective treatment.
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Hide Arm/Group Description Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 milliliter (mL) of water. Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Period Title: Overall Study
Started 10 10
In Absence of Migraine 10 10
In Presence of Migraine [1] 5 5
Completed 10 10
Not Completed 0 0
[1]
5 participants out of 10 in each arm were re-dosed in presence of migraine.
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg) Total
Hide Arm/Group Description Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water. Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
30.6  (7.50) 33.3  (7.17) 32  (7.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
10
 100.0%
9
  90.0%
19
  95.0%
Male
0
   0.0%
1
  10.0%
1
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
10
 100.0%
10
 100.0%
20
 100.0%
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 Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan
Hide Description Scintigraphic images were analyzed in a time-lapse format and regions of interest were drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with pharmacokinetic (PK) blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).
Time Frame Day 1 of each treatment administration (For 30 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Scintigraphy Population consisted of all participants with evaluable data from the scintigraphic images.
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Hide Arm/Group Description:
Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: hours (hr)
10% gastric emptying, Sumatriptan, Non-migraine Number Analyzed 10 participants 0 participants
0.100
(0.03 to 0.62)
10% gastric emptying, Sumatriptan, Migraine Number Analyzed 5 participants 0 participants
0.130
(0.05 to 0.69)
10% gastric emptying, Naproxen, Non-migraine Number Analyzed 10 participants 0 participants
1.195
(0.53 to 1.91)
10% gastric emptying, Naproxen, Migraine Number Analyzed 5 participants 0 participants
1.300
(0.85 to 2.73)
10% gastric emptying, Eletriptan, Non-migraine Number Analyzed 0 participants 10 participants
0.400
(0.00 to 0.62)
10% gastric emptying, Eletriptan, Migraine Number Analyzed 0 participants 5 participants
0.410
(0.00 to 0.69)
50% gastric emptying, Sumatriptan, Non-migraine Number Analyzed 10 participants 0 participants
0.675
(0.13 to 1.80)
50% gastric emptying, Sumatriptan, Migraine Number Analyzed 5 participants 0 participants
1.070
(0.15 to 1.42)
50% gastric emptying, Naproxen, Non-migraine Number Analyzed 10 participants 0 participants
2.260
(1.42 to 3.46)
50% gastric emptying, Naproxen, Migraine Number Analyzed 5 participants 0 participants
2.310
(1.39 to 4.38)
50% gastric emptying, Eletriptan, Non-migraine Number Analyzed 0 participants 10 participants
0.590
(0.02 to 2.57)
50% gastric emptying, Eletriptan, Migraine Number Analyzed 0 participants 5 participants
0.890
(0.02 to 2.21)
90% gastric emptying, Sumatriptan, Non-migraine Number Analyzed 10 participants 0 participants
3.020
(2.00 to 4.29)
90% gastric emptying, Sumatriptan, Migraine Number Analyzed 5 participants 0 participants
3.440
(2.26 to 4.28)
90% gastric emptying, Naproxen, Non-migraine Number Analyzed 10 participants 0 participants
4.290
(2.44 to 5.84)
90% gastric emptying, Naproxen, Migraine Number Analyzed 5 participants 0 participants
4.010
(2.81 to 8.75)
90% gastric emptying, Eletriptan, Non-migraine Number Analyzed 0 participants 10 participants
2.590
(0.03 to 4.48)
90% gastric emptying, Eletriptan, Migraine Number Analyzed 0 participants 5 participants
2.490
(0.05 to 4.23)
Complete gastric emptying,Sumatriptan,Non-migraine Number Analyzed 10 participants 0 participants
4.505
(2.50 to 6.06)
Complete gastric emptying, Sumatriptan, Migraine Number Analyzed 5 participants 0 participants
4.000
(3.02 to 8.00)
Complete gastric emptying, Naproxen, Non-migraine Number Analyzed 10 participants 0 participants
4.760
(2.50 to 8.03)
Complete gastric emptying, Naproxen, Migraine Number Analyzed 5 participants 0 participants
4.500
(3.52 to 9.97)
Complete gastric emptying, Eletriptan,Non-migraine Number Analyzed 0 participants 10 participants
3.765
(0.20 to 10.02)
Complete gastric emptying, Eletriptan, Migraine Number Analyzed 0 participants 5 participants
3.510
(0.36 to 4.53)
2.Primary Outcome
Title Mean Area Under the Drug Concentration Time Curve (AUC) From Time of Dosing Through 2 Hour Post-dose [AUC (0-2)], Through 24 Hour [AUC (0-24)] and AUC From Time of Dosing Extrapolated to Infinity [AUC (0-inf)] for Sumatriptan and Naproxen
Hide Description Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.
Time Frame Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

PK parameter population comprised of all participants in the PK concentration population for whom PK parameters were calculated.

PK concentration population comprised of all participants who had a sample obtained and analyzed. Only those participants available at the specified time points were analyzed.

Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)
Hide Arm/Group Description:
Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hr per mL (µg*hr/mL)
AUC (0-24), Sumatriptan, Non-migraine Number Analyzed 10 participants
231.526
(25.63%)
AUC (0-24), Sumatriptan, Migraine Number Analyzed 5 participants
165.707
(38.05%)
AUC (0-inf), Sumatriptan, Non-migraine Number Analyzed 9 participants
231.999
(24.76%)
AUC (0-inf), Sumatriptan, Migraine Number Analyzed 4 participants
158.036
(41.67%)
AUC (0-2), Sumatriptan, Non-migraine Number Analyzed 10 participants
65.156
(36.18%)
AUC (0-2), Sumatriptan, Migraine Number Analyzed 5 participants
54.884
(22.28%)
AUC (0-24), Naproxen, Non-migraine Number Analyzed 10 participants
570.54
(15.0%)
AUC (0-24), Naproxen, Migraine Number Analyzed 5 participants
627.06
(20.6%)
AUC (0-inf), Naproxen, Non-migraine Number Analyzed 9 participants
901.13
(21.9%)
AUC (0-inf), Naproxen, Migraine Number Analyzed 5 participants
978.39
(23.4%)
AUC (0-2), Naproxen, Non-migraine Number Analyzed 10 participants
23.16
(79.3%)
AUC (0-2), Naproxen, Migraine Number Analyzed 5 participants
24.38
(117.5%)
3.Primary Outcome
Title Mean AUC (0-inf) and AUC (0-2) for Eletriptan
Hide Description Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.
Time Frame Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PK parameter Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Relpax (Eletriptan 40 mg)
Hide Arm/Group Description:
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*hr/mL
AUC (0-inf), Non-migraine Number Analyzed 9 participants
540.669
(78.75%)
AUC (0-inf), Migraine Number Analyzed 5 participants
570.860
(94.16%)
AUC (0-2), Non-migraine Number Analyzed 10 participants
70.249
(97.29%)
AUC (0-2), Migraine Number Analyzed 5 participants
78.092
(120.65%)
4.Primary Outcome
Title Maximum Observed Drug Concentration (Cmax) for Sumatriptan and Naproxen
Hide Description Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.
Time Frame Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The PK parameter Population
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)
Hide Arm/Group Description:
Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
Sumatriptan, Non-migraine Number Analyzed 10 participants
49.900
(33.00%)
Sumatriptan, Migraine Number Analyzed 5 participants
45.676
(30.77%)
Naproxen, Non-migraine Number Analyzed 10 participants
46.34
(25.5%)
Naproxen, Migraine Number Analyzed 5 participants
56.36
(28.1%)
5.Primary Outcome
Title Cmax for Eletriptan
Hide Description Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.
Time Frame Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter Population.
Arm/Group Title Relpax (Eletriptan 40 mg)
Hide Arm/Group Description:
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Non-migraine Number Analyzed 10 participants
80.246
(61.19%)
Migraine Number Analyzed 5 participants
91.323
(74.84%)
6.Primary Outcome
Title Time of Maximal Drug Concentration (Tmax) for Sumatriptan and Naproxen
Hide Description Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.
Time Frame Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter Population
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)
Hide Arm/Group Description:
Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: hr
Sumatriptan, Non-migraine Number Analyzed 10 participants
2.000
(0.67 to 5.00)
Sumatriptan, Migraine Number Analyzed 5 participants
1.500
(0.33 to 4.50)
Naproxen, Non-migraine Number Analyzed 10 participants
4.50
(1.5 to 8.0)
Naproxen, Migraine Number Analyzed 5 participants
4.00
(1.5 to 10.0)
7.Primary Outcome
Title Tmax for Eletriptan
Hide Description Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction.
Time Frame Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK parameter Population
Arm/Group Title Relpax (Eletriptan 40 mg)
Hide Arm/Group Description:
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: hr
Non-migraine Number Analyzed 10 participants
2.500
(0.83 to 6.00)
Migraine Number Analyzed 5 participants
2.000
(1.00 to 5.50)
8.Primary Outcome
Title Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet
Hide Description Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).
Time Frame Day 1 of each treatment administered (For 30 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Scintigraphy Population
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Hide Arm/Group Description:
Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: hr
Sumatriptan, Non-migraine Number Analyzed 10 participants 0 participants
0.050
(0.05 to 0.25)
Sumatriptan, Migraine Number Analyzed 5 participants 0 participants
0.050
(0.05 to 0.20)
Naproxen, Non-migraine Number Analyzed 10 participants 0 participants
1.125
(0.67 to 4.00)
Naproxen, Migraine Number Analyzed 5 participants 0 participants
1.250
(1.00 to 3.00)
Eletriptan, Non-migraine Number Analyzed 0 participants 10 participants
0.600
(0.05 to 0.83)
Eletriptan, Migraine Number Analyzed 0 participants 5 participants
0.670
(0.05 to 0.83)
9.Primary Outcome
Title Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine
Hide Description Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).
Time Frame Day 1 of each treatment administered (For 30 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Scintigraphy Population
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Hide Arm/Group Description:
Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: hr
Sumatriptan, Non-migraine Number Analyzed 10 participants 0 participants
4.365
(2.46 to 7.01)
Sumatriptan, Migraine Number Analyzed 5 participants 0 participants
4.350
(3.15 to 5.60)
Naproxen, Non-migraine Number Analyzed 10 participants 0 participants
4.510
(2.42 to 7.01)
Naproxen, Migraine Number Analyzed 5 participants 0 participants
4.350
(4.19 to 6.40)
Eletriptan, Non-migraine Number Analyzed 0 participants 10 participants
5.530
(3.73 to 12.00)
Eletriptan, Migraine Number Analyzed 0 participants 5 participants
5.810
(3.50 to 6.50)
10.Primary Outcome
Title Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan
Hide Description Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant’s chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine).
Time Frame Day 1 of each treatment administered (For 30 days)
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Hide Analysis Population Description
Scintigraphy Population
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
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Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: hr
Sumatriptan, Non-Migraine Number Analyzed 10 participants 0 participants
2.895
(1.72 to 6.24)
Sumatriptan, Migraine Number Analyzed 5 participants 0 participants
2.990
(2.50 to 5.45)
Naproxen, Non-Migraine Number Analyzed 10 participants 0 participants
2.550
(0.24 to 3.86)
Naproxen, Migraine Number Analyzed 5 participants 0 participants
2.230
(1.95 to 3.40)
Eletriptan, Non-Migraine Number Analyzed 0 participants 10 participants
4.335
(1.80 to 11.49)
Eletriptan, Migraine Number Analyzed 0 participants 5 participants
4.140
(2.13 to 6.25)
11.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time Frame Up to Day 30
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Hide Analysis Population Description
The Safety Population consisted of all participants who were randomized and received at least one dose of study medication.
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Hide Arm/Group Description:
Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
8
  80.0%
3
  30.0%
Any SAEs
0
   0.0%
0
   0.0%
Time Frame SAEs and nSAEs were collected from start of the study treatment up to Day 30
Adverse Event Reporting Description On treatment SAEs and nSAEs were reported for Safety Population.
 
Arm/Group Title TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Hide Arm/Group Description Ten participants received single dose of radio labeled TREXIMA tablet (fixed dose combination of sumatriptan succinate 119 mg [equivalent to 85 mg of sumatriptan] and naproxen sodium 500 mg), orally, in absence of migraine. Five participants out of these participants visited clinic when they were experiencing an acute migraine attack and received TREXIMA during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water. Ten participants received single dose of Relpax (eletriptan hydrobromide, 40 mg) tablet, orally, in absence of migraine. Five participants out of theses participants visited clinic when they were experiencing an acute migraine attack and received single dose Relpax (eletriptan hydrobromide, 40 mg) tablet during migraine attack at clinic. Dosing was repeated up to 2 additional times for up to 4 total doses. Each treatment administration were separated by at least 7 days. Each dose was administered with 240 mL of water.
All-Cause Mortality
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg) Relpax (Eletriptan 40 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)   3/10 (30.00%) 
Gastrointestinal disorders     
Diarrhoea  1  2/10 (20.00%)  0/10 (0.00%) 
Nausea  1  2/10 (20.00%)  0/10 (0.00%) 
Abdominal pain  1  0/10 (0.00%)  1/10 (10.00%) 
Toothache  1  1/10 (10.00%)  0/10 (0.00%) 
Infections and infestations     
Pharyngitis streptococcal  1  1/10 (10.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Joint stiffness  1  3/10 (30.00%)  0/10 (0.00%) 
Muscle tightness  1  3/10 (30.00%)  0/10 (0.00%) 
Musculoskeletal pain  1  1/10 (10.00%)  1/10 (10.00%) 
Arthralgia  1  1/10 (10.00%)  0/10 (0.00%) 
Flank pain  1  1/10 (10.00%)  0/10 (0.00%) 
Neck pain  1  1/10 (10.00%)  0/10 (0.00%) 
Nervous system disorders     
Paraesthesia  1  3/10 (30.00%)  0/10 (0.00%) 
Dizziness  1  0/10 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Dissociation  1  1/10 (10.00%)  1/10 (10.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/10 (10.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders     
Swelling face  1  0/10 (0.00%)  1/10 (10.00%) 
Vascular disorders     
Flushing  1  1/10 (10.00%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Kori S, Byrd S, Doll W, Page R, and Sandefer E. Gastric Emptying and Absorption of a Sumatriptan with RT Technology 85mg and Naproxen Sodium 500mg Tablet. Cephalalgia 2007; Vol 27; 649.
Kori S, Byrd S, Doll W, Page R, and Sandefer E. Gastroscintigraphic Evaluation of Gastric Emptying and Absorption of Another Conventionally Formulated Triptan. Cephalalgia 2007; Vol 27; 730.
Kori S, Byrd SC, Doll WJ, Page RC, and Sandefer EP. Gastric Transit and Absorption of Sumatriptan and Naproxen from a Fixed Single-Tablet Sumatriptan RT Technology 85mg and Naproxen Sodium 500mg in Migraineurs both During and Outside a Migraine Attack: Evaluation by Gastric Scintigraphy. Headache 2007; 47(5):751.
Kori S, Doll WJ, Page RC, Byrd SC, Sandefer EP. Gastric Transit and Absorption of Eletriptan, another Conventionally Formulated Triptan, in Migraineurs both During and Outside a Migraine Attack: Evaluation by Gastric Scintigraphy. Headache 2007; 47(5):752.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00385008     History of Changes
Other Study ID Numbers: TRX105848
First Submitted: October 4, 2006
First Posted: October 6, 2006
Results First Submitted: April 13, 2017
Results First Posted: February 12, 2018
Last Update Posted: February 12, 2018