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Trial record 4 of 4 for:    ACETAMINOPHEN METABOLISM

Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass

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ClinicalTrials.gov Identifier: NCT00489424
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : September 14, 2009
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
Novartis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Placebo
Drug: Acetaminophen
Drug: Fluvastatin

  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
Placebo 2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Acetaminophen 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Fluvastatin 2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).

Participant Flow:   Overall Study
    Placebo   Acetaminophen   Fluvastatin
STARTED   267   264   262 
COMPLETED   263   259   257 
NOT COMPLETED   4   5   5 
Adverse Event                3                3                4 
Lack of Efficacy                1                0                0 
Administrative problems                0                2                1 



  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
Placebo 2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Acetaminophen 2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Fluvastatin 2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
Total Total of all reporting groups

Baseline Measures
   Placebo   Acetaminophen   Fluvastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 267   264   262   793 
Age, Customized 
[Units: Participants]
       
Between 45 and 55 years   64   69   67   200 
Between 56 and 64 years   102   98   92   292 
>=65 years   101   97   103   301 
Gender, Customized 
[Units: Participants]
       
Female   267   264   262   793 


  Outcome Measures

1.  Primary:   Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.   [ Time Frame: 0 - 3 days ]

2.  Secondary:   Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.   [ Time Frame: 0 - 3 days ]

3.  Secondary:   Proportion of Patients Who Used Rescue Medication.   [ Time Frame: 0 - 3 days ]

4.  Secondary:   Number of Rescue Medication Tablets Taken   [ Time Frame: 0 - 3 days ]

5.  Secondary:   Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.   [ Time Frame: 0 - 3 days ]

6.  Secondary:   Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.   [ Time Frame: 0 - 3 days ]

7.  Secondary:   Proportion of Patients Reporting Severe Questionnaire Symptoms.   [ Time Frame: 0 - 3 days ]

8.  Secondary:   Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity   [ Time Frame: 0 - 3 days ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00489424     History of Changes
Other Study ID Numbers: CZOL446HUS136
First Submitted: June 19, 2007
First Posted: June 21, 2007
Results First Submitted: August 6, 2009
Results First Posted: September 14, 2009
Last Update Posted: February 18, 2011