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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is to investigate if  28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.

AZD2066 Neuropathic pain - Mechanical Hypersensitivity

Research Site

A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2066 Compared to Placebo in Peripheral Neuropathic Pain Patients with Mechanical Hypersensitivity

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.

Age Continuous

Gender, Male/Female

Early termination of study for safety reasons leading to fewer subjects analyzed than originally planned.

Change in mean numerical rating scale (NRS) pain score from baseline to last 5 days on treatment

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

Patients with ≥30% reduction from baseline in NRS pain intensity score (responder rate) at Day 28

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

Patients with ≥50% reduction from baseline in NRS pain intensity score (responder rate) at Day 28

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

Patients with Patient Global Impression of Change (PGIC) score of at least “much improved” (responder rate) at Day 28

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.

Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index from baseline to Day 28

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.

Change in SF-MPQ Affective Index from baseline to Day 28

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.

Change in Brief Pain Inventory-Short Form (BPI-SF) pain severity from baseline to Day 28

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.

Change in BPI-SF pain interference from baseline to Day 28

Overall Study

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.

Arms	Assigned Interventions
Experimental: A	Drug: AZD2066 Capsule, once daily
Placebo Comparator: B	Drug: Placebo Capsule, once daily

AZD2066 Neuropathic pain - Mechanical Hypersensitivity - NP-MH

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

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Sponsors

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Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=229&filename=CSR-D0475C00016.pdf

CSR-D0475C00016.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator