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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

Tablets, 150 mg once daily in the morning.

Tablets, 20 mg once daily in the morning.

Tablets, placebo, once daily in the morning.

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy

Research Site

A study to investigate the analgesic efficacy of AZD2423 compared with placebo

Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.

Age Continuous

Gender, Male/Female

Change from baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain score.

Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable.

Change from baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain score.

Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.
Responder= NRS Average Pain score reduction ≥30% (yes/no)

Number of participants with at least 30% decrease from baseline in Numerical Rating Scale (NRS) Average Pain score at Day 28.

Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.
Responder= NRS Average Pain score reduction ≥50%  (yes/no)

Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.

Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (sympthom), 10=Worst (sympthom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.

Change from baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total score.

Overall Study

The study had an enrolment phase of up to 35 days (including wash-out and baseline periods), a 28-day treatment phase, and a follow-up phase of 7-14 days. Participants were randomly assigned to blinded treatment in a 1:1:1 ratio either to AZD2423 20 mg, AZD2423 150 mg or placebo.

Arms	Assigned Interventions
Experimental: AZD2423, 150 mg Tablets, 150 mg once daily in the morning.	Drug: AZD2423 150 mg tablet
Experimental: AZD2423, 20 mg Tablets, 20 mg once daily in the morning.	Drug: AZD2423 20 mg tablet
Placebo Comparator: Placebo Tablets, placebo, once daily in the morning.	Drug: Placebo Placebo

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=204&filename=CSR-D2600C00005.pdf

CSR-D2600C00005.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator