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Sleep and Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00936598
Recruitment Status : Terminated (Investigator-initiated termination of approval due to problems with recruitment.)
First Posted : July 10, 2009
Results First Posted : July 20, 2012
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
Dana Bovbjerg, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Sleep
Endometrial Neoplasms
Pain
Interventions: Drug: zolpidem
Drug: sugar pill

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between January 2010 and May 2010 at Magee Womens Hospital and Mercy Hospital. All participants who were recruited were assigned to one arm or the other.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant in the placebo group was found to be ineligible after consent before starting the study (before being provided with take home materials).

Reporting Groups
  Description
Zolpidem Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Sugar Pill Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.

Participant Flow:   Overall Study
    Zolpidem   Sugar Pill
STARTED   4   1 
COMPLETED   2   1 
NOT COMPLETED   2   0 
Withdrawal by Subject                1                0 
Ineligible after consent                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zolpidem Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Sugar Pill Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
Total Total of all reporting groups

Baseline Measures
   Zolpidem   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   1   5 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   3   1   4 
>=65 years   1   0   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (20.7)   60  (0)   54.4  (18.2) 
Gender 
[Units: Participants]
     
Female   4   1   5 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   4   1   5 


  Outcome Measures

1.  Primary:   Brief Pain Inventory (Short-form)   [ Time Frame: at the clinical follow-up appointment approximately 7-10 days after surgery ]

2.  Secondary:   Pain Severity Visual Analogue Scale   [ Time Frame: each of the days following surgery until the clinical follow-up appointment ]

3.  Secondary:   Daily Analgesic Medication Consumption (Morphine Equivalency)   [ Time Frame: daily from the day of surgery until the clinical follow-up appointment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor
Organization: University of Pittsburgh
phone: 412-623-5965
e-mail: bovbjergdh@upmc.edu



Responsible Party: Dana Bovbjerg, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00936598     History of Changes
Other Study ID Numbers: PRO09040160
PCI-09-027 ( Other Identifier: University of Pittsburgh Cancer Institute )
First Submitted: July 8, 2009
First Posted: July 10, 2009
Results First Submitted: June 15, 2012
Results First Posted: July 20, 2012
Last Update Posted: April 24, 2014