A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106)(P05701AM2) (Aquamarine)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: February 29, 2008
Last updated: September 26, 2013
Last verified: September 2013

To investigate the long-term efficacy and safety of treatment

with Org 50081, compared to placebo, in patients with chronic primary insomnia. Primary efficacy variable is Total

Sleep Time (TST).

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Mental Disorders
Sleep Disorders
Sleep Disorder, Intrinsic
Drug: Org 50081
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Outpatient Trial, Investigating the Efficacy and Safety of Org 50081 in Adult Patients With Chronic Primary Insomnia

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Total Sleep Time as recorded daily in the sleep diary [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate the long-term efficacy in improving sleep latency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To investigate the long term efficacy on other sleep maintenance parameters and on sleep quality and satisfaction with sleep duration. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To investigate long-term safety and tolerability. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To investigate the effects of discontinuation after long-term treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To explore the effect on functional and quality of life outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 460
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Org 50081 one tablet once a day
Drug: Org 50081
one tablet once a day
Placebo Comparator: Arm 2
one tablet once a day
Drug: Placebo
One tablet once a day

Detailed Description:

Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints.

The maleic acid salt of Org 4420, code name Org 50081, was selected for development in the treatment of insomnia. The first clinical trial with Org 50081 was a proof-of-concept trial with a four-way cross-over design. All 3 Org 50081 dose groups showed a statistically significant positive effect on TST (objective and subjective) and WASO, as compared to placebo.

The current study is designed to assess the long-term efficacy and safety of Org 50081 in a double-blind, randomized, placebo-controlled, parallel group outpatient trial in patients suffering from chronic primary insomnia.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • are at least 18 and less than 65 years;
  • sign written informed consent after the scope and nature of the investigation have been explained;
  • have shown capability to complete the LogPad questionnaires;
  • have difficulty falling asleep, maintaining sleep or have early morning awakening;

Exclusion Criteria:

  • Significant medical or psychiatric illness causing sleep disturbances.
  • Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
  • Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
  • Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
  • Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
  • Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
  • Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
  • Routinely nap during the day.
  • Have a BMI of 36 or more.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00631657     History of Changes
Other Study ID Numbers: P05701, 21106
Study First Received: February 29, 2008
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck Sharp & Dohme Corp.:
placebo controlled
double blind

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Sleep Initiation and Maintenance Disorders
Sleep Disorders
Sleep Disorders, Intrinsic
Schizophrenia and Disorders with Psychotic Features
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014