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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 AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared with Placebo in Patients with Painful Diabetic Neuropathy

Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.

Reserach Site

Research Site

Reasearch 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 with Placebo in Patients with Painful Diabetic Neuropathy

Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).
Mean pain intensity for 5-day baseline period (evening Day -6 to moning 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 numerical rating scale (NRS)(0-10).  0=No pain, 10=Worst pain imaginable.

Age Continuous

Gender, Male/Female

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

Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day.  Baseline value= mean pain intensity for the 5-day baseline period.  NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.

Daily Numerical Rating Scale (NRS) pain scores and change from baseline over time to Day 28.

Pain intensity score reduction=(change from baseline at D28/baseline)*100
Responder= pain intensity score reduction ≥30%  (yes/no)?
Responder rate= (no. of responders/total no. of patients)*100

Number of patients with >=30% reduction from baseline in Numerical Rating Scale (NRS) pain intensity score at Day 28

Pain intensity score reduction= (change from baseline D28/baseline)*100
Responder=pain intensity score reduction ≥50% (Yes/No)?
Responder rate= (no. of responders/total no. of patients)*100

Number of patients with >=50% reduction from baseline in Numerical Rating Scale (NRS) pain intensity score at Day 28

Patient Global Impression of Change (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

Number of patients with Patient Global Impression of Change (PGIC) score of at least “much improved” 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 McGill Pain Questionnaire Short Form (MPQ-SF) 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 McGill Pain Questionnaire Short Form (MPQ-SF) 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 Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.

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 Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.

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

Overall Study

The study consisted of a 42-day enrollment phase (including washout and baseline period), a 28-day treatment phase (10-day inpatient and 18-day outpatient) where patients were randomized to AZD2066 or placebo, and a 7-day follow-up phase.  Patients randomized to treatment with AZD2066 received 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.

Arms	Assigned Interventions
Experimental: 1	Drug: AZD2066 Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
Placebo Comparator: 2	Drug: Placebo Capsule, once daily

Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared with Placebo in Patients with Painful Diabetic Neuropathy

Official Title

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Healthy volunteers

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=228&filename=CSR-D0475C00009.pdf

CSR-D0475C00009.pdf

Trial Results Summaries

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