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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 primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.

Study to investigate the analgesic efficacy of a single dose of AZD1386

Research Site

A Double-blind, Randomized, Placebo and Naproxen Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386, in Patients Undergoing Impacted Mandibular Third Molar Extraction

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).

Age Continuous

Gender, Male/Female

Sum of pain intensity difference in percent (SPID%)

Just before dosing

15 minutes

30 minutes

45 minutes

1 hour

1 hour 15 minutes

1 hour 30 minutes

1 hour 45 minutes

2 hours

2 hours 30 minutes

3 hours

4 hours

5 hours

6 hours

7 hours

8 hours

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.

Pain intensity (PI) by using Visual Analogue Scale (VAS) (0-100 mm)

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.

Time to first perceptible pain relief

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.

Time to first meaningful pain relief

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

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

VAS Pain intensity at rescue intake

VAS pain on jaw movement at rescue intake

Overall 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.

Arms	Assigned Interventions
Experimental: AZD1386	Drug: AZD1386 95mg, oral solution, single dose
Active Comparator: Naproxen	Drug: Naproxen 500mg, capsule, single dose
Placebo Comparator: Placebo Placebo matching AZD1386	Drug: Placebo AZD1386 Placebo oral solution

Study to investigate the analgesic efficacy of a single dose of AZD1386

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=367&filename=CSR-D5090C00010.pdf

CSR-D5090C00010.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator