NCT00506389

A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

Completed Phase 3 Results posted Last updated 2 October 2018

What this trial tests

Phase 3 trial testing Esmirtazapine in Insomnia in 419 participants. Completed in 13 February 2008.

Timeline

6 June 2007

Primary endpoint
13 February 2008

13 February 2008

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	419
Start date	6 June 2007
Primary completion	13 February 2008
Estimated completion	13 February 2008

Drugs / interventions tested

• Esmirtazapine — full drug profile →
• Placebo

Conditions studied

• Insomnia — all drugs for Insomnia →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Insomnia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period Primary · From Day 1 to Day 36

WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.

Group	Value	95% CI
Esmirtazapine 3.0 mg	45.6	± 25.7
Esmirtazapine 4.5 mg	45.5	± 26.5
Placebo	76.1	± 46.0

Average Latency to Persistent Sleep (LPS) During the In-Treatment Period Secondary · From Day 1 to Day 36

LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.

Group	Value	95% CI
Esmirtazapine 3.0 mg	28.7	± 28.4
Esmirtazapine 4.5 mg	26.1	± 23.0
Placebo	40.5	± 27.3

Average Subjective Total Sleep Time (TST) During the In-Treatment Period Secondary · From Day 1 to Day 36

TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.

Group	Value	95% CI
Esmirtazapine 3.0 mg	384.6	± 63.6
Esmirtazapine 4.5 mg	384.6	± 66.2
Placebo	351.6	± 57.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to Day 50. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Esmirtazapine 3.0 mg In-treatment

Serious: 0/139 (0%)

Deaths: —

Esmirtazapine 4.5 mg In-treatment

Serious: 1/138 (1%)

Deaths: —

Placebo In-treatment

Serious: 0/136 (0%)

Deaths: —

Esmirtazapine 3.0 mg Follow-up

Serious: 0/139 (0%)

Deaths: —

Esmirtazapine 4.5 mg Follow-up

Serious: 0/138 (0%)

Deaths: —

Placebo Follow-up

Serious: 0/136 (0%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Esmirtazapine 3.0 mg In-tr…	Esmirtazapine 4.5 mg In-tr…	Placebo In-treatment	Esmirtazapine 3.0 mg Follo…	Esmirtazapine 4.5 mg Follo…	Placebo Follow-up
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Pneumonia streptococcal	Infections and infestations	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Esmirtazapine 3.0 mg In-tr…	Esmirtazapine 4.5 mg In-tr…	Placebo In-treatment	Esmirtazapine 3.0 mg Follo…	Esmirtazapine 4.5 mg Follo…	Placebo Follow-up
Somnolence	Nervous system disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—

Most-reported serious reactions: Neutropenia, Pneumonia streptococcal, Sepsis.

Data from ClinicalTrials.gov NCT00506389 adverse events section.

Sponsor's own description

The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.