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Trial Outcomes & Findings for Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386 (NCT NCT00672646)

NCT ID: NCT00672646

Last Updated: 2012-06-08

Results Overview

Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

103 participants

Primary outcome timeframe

from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

Results posted on

2012-06-08

Participant Flow

The study was performed at Lifetree Clinical Research, Salt Lake City, USA, during April-June 2008. 135 participants enrolled in the study, 103 randomized and 99 patients completed the study.

Screening for eligibility prior to the residential day, and selecting the patients that request pain relief, due to pain from the dental surgical area, within 6 hours after the end of the administration of the local anaesthetic.

Participant milestones

Participant milestones
Measure
AZD1386
AZD1386 95 mg oral solution
Naproxen
Naproxen 500 mg capsule
Placebo
AZD1386 Placebo oral solution
Overall Study
STARTED
40
23
40
Overall Study
COMPLETED
40
22
37
Overall Study
NOT COMPLETED
0
1
3

Reasons for withdrawal

Reasons for withdrawal
Measure
AZD1386
AZD1386 95 mg oral solution
Naproxen
Naproxen 500 mg capsule
Placebo
AZD1386 Placebo oral solution
Overall Study
Lost to Follow-up
0
1
2
Overall Study
Withdrawal by Subject
0
0
1

Baseline Characteristics

Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AZD1386
n=40 Participants
AZD1386 95 mg oral solution
Naproxen
n=23 Participants
Naproxen 500 mg capsule
Placebo
n=40 Participants
AZD1386 Placebo oral solution
Total
n=103 Participants
Total of all reporting groups
Age Continuous
21.5 year
STANDARD_DEVIATION 4.4 • n=5 Participants
21 year
STANDARD_DEVIATION 4.8 • n=7 Participants
21.9 year
STANDARD_DEVIATION 4.8 • n=5 Participants
21.5 year
STANDARD_DEVIATION 4.6 • n=4 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Male
40 Participants
n=5 Participants
23 Participants
n=7 Participants
40 Participants
n=5 Participants
103 Participants
n=4 Participants

PRIMARY outcome

Timeframe: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).

Outcome measures

Outcome measures
Measure
AZD1386
n=40 Participants
AZD1386 95 mg oral solution
Naproxen
n=23 Participants
Naproxen 500 mg capsule
Placebo
n=40 Participants
AZD1386 Placebo oral solution
Sum of Pain Intensity Difference in Percent (SPID%)
35.5 percentage of pain intensity change * h
Interval -156.4 to 603.7
171.8 percentage of pain intensity change * h
Interval -723.8 to 709.8
-7.5 percentage of pain intensity change * h
Interval -106.5 to 588.7

SECONDARY outcome

Timeframe: Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.

0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately.

Outcome measures

Outcome measures
Measure
AZD1386
n=40 Participants
AZD1386 95 mg oral solution
Naproxen
n=23 Participants
Naproxen 500 mg capsule
Placebo
n=40 Participants
AZD1386 Placebo oral solution
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
15 minutes
33 units on VAS scale
Interval 0.0 to 85.0
54 units on VAS scale
Interval 9.0 to 89.0
45 units on VAS scale
Interval 3.0 to 96.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
30 minutes
30.5 units on VAS scale
Interval 0.0 to 92.0
61 units on VAS scale
Interval 17.0 to 90.0
47 units on VAS scale
Interval 3.0 to 100.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
45 minutes
28.5 units on VAS scale
Interval 0.0 to 96.0
61 units on VAS scale
Interval 12.0 to 89.0
51 units on VAS scale
Interval 5.0 to 100.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
1 hour
31.5 units on VAS scale
Interval 1.0 to 84.0
52 units on VAS scale
Interval 5.0 to 94.0
55 units on VAS scale
Interval 7.0 to 100.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
1 hour 15 minutes
35.5 units on VAS scale
Interval 6.0 to 100.0
46 units on VAS scale
Interval 3.0 to 86.0
53 units on VAS scale
Interval 7.0 to 100.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
1 hour 30 minutes
41 units on VAS scale
Interval 8.0 to 100.0
38 units on VAS scale
Interval 3.0 to 89.0
44 units on VAS scale
Interval 4.0 to 100.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
1 hour 45 minutes
50.5 units on VAS scale
Interval 8.0 to 93.0
35 units on VAS scale
Interval 1.0 to 70.0
50 units on VAS scale
Interval 3.0 to 93.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
2 hours
50.5 units on VAS scale
Interval 9.0 to 91.0
28 units on VAS scale
Interval 0.0 to 76.0
37 units on VAS scale
Interval 1.0 to 79.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
2 hours 30 minutes
30.5 units on VAS scale
Interval 4.0 to 81.0
26 units on VAS scale
Interval 0.0 to 79.0
23 units on VAS scale
Interval 0.0 to 87.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
3 hours
24.5 units on VAS scale
Interval 0.0 to 71.0
21 units on VAS scale
Interval 0.0 to 73.0
20 units on VAS scale
Interval 0.0 to 92.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
4 hours
14 units on VAS scale
Interval 0.0 to 89.0
18 units on VAS scale
Interval 0.0 to 70.0
14.5 units on VAS scale
Interval 0.0 to 79.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
5 hours
19 units on VAS scale
Interval 0.0 to 83.0
10 units on VAS scale
Interval 0.0 to 73.0
14 units on VAS scale
Interval 0.0 to 51.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
6 hours
14 units on VAS scale
Interval 0.0 to 68.0
7 units on VAS scale
Interval 0.0 to 68.0
13 units on VAS scale
Interval 0.0 to 40.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
7 hours
15 units on VAS scale
Interval 0.0 to 55.0
6 units on VAS scale
Interval 0.0 to 66.0
14 units on VAS scale
Interval 0.0 to 44.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
8 hours
14 units on VAS scale
Interval 0.0 to 56.0
4 units on VAS scale
Interval 0.0 to 73.0
11.5 units on VAS scale
Interval 0.0 to 44.0
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
Just before dosing
50 units on VAS scale
Interval 16.0 to 86.0
48 units on VAS scale
Interval 13.0 to 90.0
46.5 units on VAS scale
Interval 13.0 to 87.0

SECONDARY outcome

Timeframe: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours.

Outcome measures

Outcome measures
Measure
AZD1386
n=40 Participants
AZD1386 95 mg oral solution
Naproxen
n=23 Participants
Naproxen 500 mg capsule
Placebo
n=40 Participants
AZD1386 Placebo oral solution
Time to First Perceptible Pain Relief
0.3 hour
Interval 0.2 to 0.9
0.8 hour
Interval 0.4 to 4.2
1.3 hour
Interval 0.4 to 8.0

SECONDARY outcome

Timeframe: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

First meaningful pain relief is the time when the participant's pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours.

Outcome measures

Outcome measures
Measure
AZD1386
n=40 Participants
AZD1386 95 mg oral solution
Naproxen
n=23 Participants
Naproxen 500 mg capsule
Placebo
n=40 Participants
AZD1386 Placebo oral solution
Time to First Meaningful Pain Relief
8.0 hour
Interval 0.9 to 8.0
4.2 hour
Interval 1.5 to 8.0
8.0 hour
Interval 6.5 to 8.0

SECONDARY outcome

Timeframe: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product

Population: Only participants that took rescue medication are included in this analysis.

0 = 'No pain' 100 ='Worst pain imaginable'

Outcome measures

Outcome measures
Measure
AZD1386
n=32 Participants
AZD1386 95 mg oral solution
Naproxen
n=11 Participants
Naproxen 500 mg capsule
Placebo
n=32 Participants
AZD1386 Placebo oral solution
VAS Pain Intensity at Rescue Intake
61.0 units on a VAS scale
Interval 19.0 to 100.0
69.0 units on a VAS scale
Interval 26.0 to 93.0
70.5 units on a VAS scale
Interval 14.0 to 100.0

SECONDARY outcome

Timeframe: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product

Population: Only participants that took rescue medication are included in this analysis.

0 = 'No pain' 100 ='Worst pain imaginable'

Outcome measures

Outcome measures
Measure
AZD1386
n=32 Participants
AZD1386 95 mg oral solution
Naproxen
n=11 Participants
Naproxen 500 mg capsule
Placebo
n=32 Participants
AZD1386 Placebo oral solution
VAS Pain on Jaw Movement at Rescue Intake
65.0 Units on a VAS scale
Interval 8.0 to 100.0
81.0 Units on a VAS scale
Interval 16.0 to 96.0
73.5 Units on a VAS scale
Interval 5.0 to 100.0

Adverse Events

AZD1386

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Naproxen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
AZD1386
n=40 participants at risk
AZD1386 95 mg oral solution
Naproxen
n=23 participants at risk
Naproxen 500 mg capsule
Placebo
n=40 participants at risk
AZD1386 Placebo oral solution
General disorders
CHILLS
5.0%
2/40
0.00%
0/23
0.00%
0/40
Nervous system disorders
DIZZINESS
0.00%
0/40
0.00%
0/23
10.0%
4/40
Nervous system disorders
HEADACHE
5.0%
2/40
0.00%
0/23
5.0%
2/40

Additional Information

Gerard Lynch

AstraZeneca

Results disclosure agreements

  • Principal investigator is a sponsor employee AstraZeneca has the exclusive right to publish the results of the study.
  • Publication restrictions are in place

Restriction type: OTHER