| Trial ID: | L6673 |
| Source ID: | NCT00869128
|
| Associated Drug: |
Circadin
|
| Title: |
A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00869128/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Insomnia
|
| Interventions: |
DRUG: Circadin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Sleep Efficiency, Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period, 3 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Neurim Pharmaceuticals Ltd.
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
1995-11
|
| Completion Date: |
1997-03
|
| Results First Posted: |
2009-03-25
|
| Last Update Posted: |
2009-05-01
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00869128
|
