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Trial record 47 of 145 for:    Hydrocodone

Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT) (LDOT)

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ClinicalTrials.gov Identifier: NCT00385684
Recruitment Status : Completed
First Posted : October 11, 2006
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alzheimer Disease
Dementia
Dementia, Vascular
Pain
Interventions: Drug: hydrocodone/APAP w placebo PRN
Drug: hydrocodone/APAP
Drug: placebo with hydrocodone/APAP PRN

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A1 and Then A2 Then Phase B

This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.

Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen.

A2 THEN A1 Then Phase B

This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.

Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen.


Participant Flow for 3 periods

Period 1:   FIRST INTERVENTION OF PHASE A
    A1 and Then A2 Then Phase B   A2 THEN A1 Then Phase B
STARTED   6   5 
COMPLETED   5   5 
NOT COMPLETED   1   0 
Death                1                0 

Period 2:   SECOND INTERVENTION OF PHASE A
    A1 and Then A2 Then Phase B   A2 THEN A1 Then Phase B
STARTED   5   5 
COMPLETED   5   3 
NOT COMPLETED   0   2 
Adverse Event                0                1 
study drug recall                0                1 

Period 3:   PHASE B
    A1 and Then A2 Then Phase B   A2 THEN A1 Then Phase B
STARTED   5   3 
COMPLETED   5   3 
NOT COMPLETED   0   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.
Veterans with severe dementia residing in VA nursing home.

Reporting Groups
  Description
ALL STUDY PARTICIPANTS

This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.

Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen.


Baseline Measures
   ALL STUDY PARTICIPANTS 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   0 
>=65 years   11 
Gender 
[Units: Participants]
 
Female   0 
Male   11 


  Outcome Measures

1.  Primary:   Pain Assessment in Advanced Dementia (PAINAD)   [ Time Frame: Two (2) weeks ]

2.  Secondary:   Pain Assessment in Advanced Dementia (PAINAD)   [ Time Frame: 6 weeks ]


  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: Andrea L. Snow
Organization: Tuscaloosa VA Medical Center
phone: 205-554-2000 ext 2260
e-mail: lynn.snow@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00385684     History of Changes
Other Study ID Numbers: F4483-I
First Submitted: October 6, 2006
First Posted: October 11, 2006
Results First Submitted: June 2, 2014
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015