Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Non-inferiority, Double-blind, Unicenter Clinical Trial With Two Treatment Arms - Test Group With Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
Brief Summary: The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.


Options:
A: Inclusion Criteria:

* • Diagnosis of insomnia based on DSM-IV criteria for insomnia due to a general medical condition (low-back pain);

  * The insomnia must not predate the onset of low-back pain by more than 1 month;
  * Usual nightly TST (Total Sleep Time) \< 6.5 hours and/or usual SOL (Sleep Onset Latency) \> 30 minutes for the last month prior to screening;
  * ISI (Insomnia Severity Index) \> 14 (at least moderate insomnia);
  * Age 21-64 years;
  * Greater than 40 on VAS (Visual Analog Scale) for pain (scale is 0-no pain to 100-worst imaginable pain);
  * Patient Global Impression of Pain of at least 3 (on a 1-5 scale, indicating at least moderate severity);
  * reported Back pain must be greater than reported leg pain, and there must be no signs of spinal nerve root compression;
  * presence of normal motor strength on exam;
  * duration of chronic low back pain of greater than three months;
  * low back pain location must be inferior to T12 and superior to the gluteal fold.

Exclusion Criteria:

* • Significant medical or neurological illness in excess of that which is directly responsible for the chronic low back pain;

  * the presence of an active and significant psychiatric disease with a substantive impact on sleep;
  * meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months;
  * current pregnancy; history of hypersensitivity, intolerance, or contraindication to Naproxen/Lansoprazole or Eszopiclone;
  * baseline creatinine of 2.0 or greater; patient taking other medications having significant renal effects (e.g. lithium, ACE inhibitor, angiotensin receptor antagonist, or thiazide/loop diuretics);
  * patients taking other anticoagulants; patients having an allergy to aspirin; history of diagnosed gastric or duodenal ulcer;
  * history of bleeding or clotting diathesis; lifetime history of myocardial infarction or cerebrovascular accident;
  * Elevated PT/PTT/INR (Prothrombin Time, Partial Thromboplastin Time, International Normalized Ratio)at screening;
  * Abnormal kidney function detected in screening labs;
  * history of back related surgery within the past 3 months; history of corticosteroid use in the past 30 days;
  * presence of currently pending litigation or worker's compensation claim related to the chronic low back pain;
  * inability to follow study procedures or complete the study; or the use of any medications that could affect sleep within 5 half-lives of screening;
  * history of back surgery within the past 2 years with the exception of a discectomy;
  * pregnant or lactating females;
  * women of child-bearing potential who will not agree to use approved means of birth control during the trial;
  * history of any surgery within the past one month; history of any major physical trauma within the last 6 months;
  * history of corticosteroid use within the last 90 days; diagnosis of rheumatoid or psoriatic arthritis;
  * history of fibromyalgia;
  * presence of spondyloarthropathy;
  * presence of sciatica;
  * spinal stenosis;
  * presence of any vertebral fractures, spondylolisthesis; or radicular back pain.
B: Inclusion criteria:

1. Participants who submit written informed consent for study entry.
2. Participants aged greater than or equal to 20 and less than 85 years of age at the time of obtaining informed consent.
3. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version or diagnosed with insomnia associated with psychiatric or physical disorder(s).
4. Participants with both of the following conditions which are persistent for 4 weeks or longer before the start of observation period:

   * Total sleep time is less than or equal to 390 minutes for more than or equal to 3 days a week
   * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week
5. Participants with data at least 2 consecutive days in diary entries during observation period and confirmed to meet the following two criteria:

   * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
   * Time to fall asleep taking more than or equal to 30 minutes for more than or equal to 3 days a week

Exclusion criteria:

1. Participants with a present or history of the following disease specified in

   Mini-International Neuropsychiatric Interview (M.I.N.I.) Japanese version 5.0:
   * Risk of suicide
   * (Mild) manic episode
   * Post-traumatic stress disorder (PTSD)
   * Alcohol dependence and abuse
   * Drug (non-alcohol) dependence and abuse
   * Anorexia nervosa
   * Bulimia nervosa
   * Anti-social personality disorder
2. Participants with pharmacologically induced insomnia (drug-induced insomnia).
3. Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia.
4. Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough.
5. Participants with unstable primary disease presenting insomnia during 4 weeks before the start of observation period.
6. Participants with organic mental disorder.
C: Inclusion Criteria:

1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
2. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

   * Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
   * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
3. Participants who meet both of the following based on polysomnogram (PSG) in observation period:

   * Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
   * Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

1. Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
2. Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
3. Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
4. Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
5. Participants with organic mental disorder.
D: Inclusion Criteria:

* Sign the informed consent form for the study;
* Be ≥ 20 to ≥ 64 years old;
* Have diagnosis of symptomatic primary insomnia for at least 3 months;
* Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;
* Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).

Exclusion Criteria:

* Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;
* Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;
* Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;
* Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;
* History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);
* History of substance abuse or dependence;
* Patients with severe co-morbidities (at the investigator's opinion);
* Presence of liver disorders, cirrhosis or liver failure;
* Presence of psychiatric disorders diagnosed at the adult life or currently under treatment;
* Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.

Answer: D