Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A multicentric, randomized, comparative clinical trial of Armodafinil versus Modafinil in patients with excessive sleepiness associated with shift work sleep disorder (SWSD).
Scientific Title of Study
A multicentric, randomized, comparative clinical trial of Armodafinil versus Modafinil in patients with excessive sleepiness associated with shift work sleep disorder (SWSD).
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr. Arun V. Marwale
Designation
Affiliation
Address
Shradha Nursing Home 10 B, Samatanagar, Opp. Brotherhood church, Aurangabad BIHAR 431001 India
Phone
02402356705
Fax
Email
a.marwale@rediffmail.com
Details of Contact Person Scientific Query
Name
Dr. Onkar Swami
Designation
Affiliation
Address
Emcure Pharmaceuticals Ltd Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi Pune MAHARASHTRA 411057 India
Phone
020-39821000
Fax
020-39821019
Email
Onkar.Swami@emcure.co.in
Details of Contact Person Public Query
Name
Dr. Onkar Swami
Designation
Affiliation
Address
Emcure Pharmaceuticals Ltd Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi Pune MAHARASHTRA 411057 India
Phone
020-39821000
Fax
020-39821019
Email
Onkar.Swami@emcure.co.in
Source of Monetary or Material Support
Emcure Pharmaceuticals Ltd Pune.
Primary Sponsor
Name
Emcure Pharmaceuticals Ltd Pune.
Address
Type of Sponsor
Details of Secondary Sponsor
Name
Address
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 22
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr. Asawari A. Dhavale
A J Medical Care Pvt Ltd
Plot No 8 C, Survey No 288, Raisoni Industrial Estate,Mann, Taluka Mulshi-411057 Pune MAHARASHTRA
Independent Ethics Committee, A J Medical care Pvt Ltd, for Dr. Asawari Dhavale
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr Hemal Mehta
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Abhay Paliwal
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Arun V. Marwale
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Dinesh V. Tembe
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Gurpreet Dhingra
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Hemang Desai
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Kausar Abbasi
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Mahesh Padsalge
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Malhar Dave
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Manoj Rohra
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Preeti Devnani
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Sanjay Phadke
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Shrikant Papinwar
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Sundeep Jadhav
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Ujwal Sardesai
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Umesh Nagapurkar
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Veena G. Shinde
Approved
Independent Ethics Committee, Dhanashree Hospital, for Dr. Vilas Bhailume
Approved
Noble Hospital Institutional Ethics Committee for Dr. Dileep Mane
Approved
Noble Hospital Institutional Ethics Committee, for Dr. S. K. Raut
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Excessive sleepiness associated with shift work sleep disorder,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Armodafinil
150 mg orally once day approximately 1 hour prior to the start of work shift
Comparator Agent
Modafinil
200 mg orally once day approximately 1 hour prior to the start of work shift
Inclusion Criteria
Age From
Age To
Gender
Details
1) Male, non-pregnant female and female taking suitable precautions for contraception between the ages of 18 and 60 years worked each month at least five night shifts for 12 hours or less, with 6 hours or more worked between 10 p.m. and 8 a.m. and at least three shifts occurring consecutively.
2) Patients with Shift work sleep disorder diagnosed by following (The international classification of sleep disorder) criteria:
A. The patient has a primary complaint of insomnia or excessive sleepiness.
B. The primary complaint is temporally associated with a work period (usually night work) that occurs during the habitual sleep phase.
C. No medical or mental disorder accounts for the symptoms.
D. The symptoms do not meet criteria for any other sleep disorder producing insomnia or excessive sleepiness (e.g., time-zone change [jet lag] syndrome).
Minimal Criteria: A plus B.
3) Willing to give written informed consent & willing to comply with trial protocol
ExclusionCriteria
Details
1) Patients < 18 and > 60 years of age.
2) Patients with significant liver/kidney/heart diseases.
3) Presence of clinically significant, uncontrolled psychiatric or medical condition.
4) Patients with known history of hypersensitivity to formulation.
5) Patients operating an automobile or hazardous machinery.
6) Pregnant and lactating mother.
7) Female of reproductive age and willing to become pregnant.
8) Female of reproductive age using steroidal contraceptives.
9) Patients with Alcohol or drug abuse.
10) Caffeine consumption averaging more than 600 mg/day within 1 week of baseline
11) Use of other concomitant medications which inhibit, induce or metabolized by CYP450 viz: Carbamazepine, phenobarbital, rifampin, ketoconazole, erythromycin, cyclosporine, ethinyl estradiol, triazolam, phenytoin, diazepam, and propranolol, omeprazole and clomipramine etc.
12) Patients using sedative or CNS acting drugs or medication liable to affect outcome of the study (e.g. antihistamines, selective serotonin reuptake inhibitors, tricyclic antidepressants, lithium, antipsychotics, anticonvulsants, monoamine oxidase inhibitor, benzodiazepines, psychostimulants and anticoagulants).
13) Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
1)Responder rate 2)Improvement in grades based on Stanford Sleepiness Score 3)Compliance of therapy 4)Patients and physicians overall assessment for Efficacy and tolerability
Baseline, 4, 8 and 12 weeks
Secondary Outcome
Outcome
TimePoints
NIL
NIL
Target Sample Size
Total Sample Size="0" Sample Size from India="" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
Date Missing
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
10/08/2009
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="" Months="0" Days="0"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This multicentric, double blind, randomized comparative clinical trial is proposed to evaluate efficacy and safety of Armodafinil versus Modafinil in Indian patients with excessive sleepiness associated with shift work sleep disorder (SWSD). After satisfing exclusion and inclusion criteria, patients will be randomized to receive either Armodafinil or Modafinil. The duration of this study is of 12 weeks and patients will be evaluated at baseline and after 4, 8 and 12 weeks. Efficacy Variables are i)Responder rate: Percent of subject showing at least 2 grades of improvement based on Stanford Sleepiness Score ii)Improvement in grades based on Stanford Sleepiness Score iii)Compliance of therapy iv)Patients and physicians overall assessment for Efficacy and tolerability. Biochemical Parameters and ECG will be done baseline and after completion of therapy. Any adverse event if any will be recorded.