Trial Outcomes & Findings for AZD2066 Neuropathic Pain - Mechanical Hypersensitivity (NCT NCT00939094)

NCT ID: NCT00939094

Last Updated: 2012-09-27

Results Overview

Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 87 participants
• Primary outcome timeframe: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)
• Results posted on: 2012-09-27

Participant Flow

This multicenter study was conducted between August 2009 and November 2010 in the United States.

The study had an enrolment phase of up to 35 days (including washout and baseline periods), a 28-day treatment phase, and a follow-up phase of 7 days (for men and women not of childbearing potential) or 28 days (for women of childbearing potential). Patients randomized to AZD2066 received AZD2066 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.

Participant milestones

Measure	A - AZD2066 AZD2066, 12 mg capsule	2 - Placebo Placebo, capsule
Overall Study STARTED	42	45
Overall Study COMPLETED	28	35
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Measure	A - AZD2066 AZD2066, 12 mg capsule	2 - Placebo Placebo, capsule
Overall Study Adverse Event	9	0
Overall Study Withdrawal by Subject	1	6
Overall Study Lost to Follow-up	1	1
Overall Study Eligibility criteria not fulfilled	2	0
Overall Study Severe non-compliance to protocol	0	1
Overall Study Study stopped by sponsor	0	2
Overall Study Abnormal ECG findings	1	0

Baseline Characteristics

AZD2066 Neuropathic Pain - Mechanical Hypersensitivity

Baseline characteristics by cohort

Measure	A - AZD2066 n=42 Participants AZD2066, 12 mg capsule	2 - Placebo n=45 Participants Placebo, capsule	Total n=87 Participants Total of all reporting groups
Age Continuous	58.1 years STANDARD_DEVIATION 9.25 • n=5 Participants	59.3 years STANDARD_DEVIATION 14.31 • n=7 Participants	58.7 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	27 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)

Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment	-2.14 Scores (units) on NRS Standard Error 0.358	-1.26 Scores (units) on NRS Standard Error 0.337

SECONDARY outcome

Timeframe: 28 days

NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28	16 Participants	10 Participants

SECONDARY outcome

Timeframe: 28 days

Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28	10 Participants	5 Participants

SECONDARY outcome

Timeframe: 28 days

PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of " much improved" or "very much improved" Responder rate=(no. of responders/total no. of patients)*100

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28	10 Patients	10 Patients

SECONDARY outcome

Timeframe: 28 days

Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition).

Change from baseline (measured prior to randomization) to Day 28 was calculated.

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28	-6.39 Scores (units) on SF-MPQ Sensory Index Standard Error 1.278	-3.98 Scores (units) on SF-MPQ Sensory Index Standard Error 1.188

SECONDARY outcome

Timeframe: 28 days

Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).

Change from baseline (measured prior to randomization) to Day 28 was calculated.

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Change in SF-MPQ Affective Index From Baseline to Day 28	-1.1 Scores (units) on SF-MPQ Affective Index Standard Deviation 0.52	-0.9 Scores (units) on SF-MPQ Affective Index Standard Deviation 0.50

SECONDARY outcome

Timeframe: 28 days

Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28	-2.12 Scores (units) on BPI-SF pain severity Standard Error 0.385	-1.25 Scores (units) on BPI-SF pain severity Standard Error 0.360

SECONDARY outcome

Timeframe: 28 days

Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.

Outcome measures

Measure	A - AZD2066 n=30 Participants AZD2066, 12 mg capsule	2 - Placebo n=38 Participants Placebo, capsule
Change in BPI-SF Pain Interference From Baseline to Day 28	-1.98 Scores on BPI-SF pain interference Standard Error 0.376	-1.72 Scores on BPI-SF pain interference Standard Error 0.360

Adverse Events

A - AZD2066

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

2 - Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	A - AZD2066 n=42 participants at risk AZD2066, 12 mg capsule	2 - Placebo n=44 participants at risk Placebo, capsule
Psychiatric disorders Psychotic Disorder	2.4% 1/42	0.00% 0/44

Other adverse events

Measure	A - AZD2066 n=42 participants at risk AZD2066, 12 mg capsule	2 - Placebo n=44 participants at risk Placebo, capsule
Nervous system disorders Dizziness	23.8% 10/42	6.8% 3/44
Nervous system disorders Headache	16.7% 7/42	9.1% 4/44
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 4/42	4.5% 2/44
Gastrointestinal disorders Diarrhea	7.1% 3/42	4.5% 2/44
Psychiatric disorders Insomnia	7.1% 3/42	2.3% 1/44
Nervous system disorders Paraesthesia	7.1% 3/42	0.00% 0/44
Nervous system disorders Somnolence	7.1% 3/42	0.00% 0/44
Gastrointestinal disorders Constipation	0.00% 0/42	6.8% 3/44

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee No publication or presentation with respect to the study until the earlier of 1) publication of the first Multi-Center Publication and 2) the second anniversary of the completion, or termination of the study. Sponsor to review at least 60 days prior submission. Sponsor can withhold material for submission for additional 90 days
• Publication restrictions are in place

Restriction type: OTHER