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Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia

NCT00755508 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2012-02-28

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of ramelteon, once daily (QD), taken in combination with Gabapentin for treating insomnia.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

Ramelteon and gabapentin

Ramelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week.

DRUG

Ramelteon and gabapentin

Ramelteon 8 mg, tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.

DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.

DRUG

Gabapentin

Ramelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.

DRUG

Placebo

Ramelteon placebo-matching tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.

Sponsors & Collaborators

Principal Investigators

  • Sr. VP Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-09-30
Completion
2006-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00755508 on ClinicalTrials.gov