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Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C (STEALTHC-2)

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ClinicalTrials.gov Identifier: NCT00495391
Recruitment Status : Completed
First Posted : July 3, 2007
Results First Posted : January 6, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Nitazoxanide
Drug: Placebo
Biological: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 64
Recruitment Details This study recruited patients from 10 study sites in the United States, including a Veterans Administrations hospital.
Pre-assignment Details  
Arm/Group Title NTZ+PR Placebo+PR
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Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Period Title: Overall Study
Started 42 22
From Baseline to Week 8 31 20
From Baseline to Week 16 24 11
From Baseline to End of Treatment 6 1
From Baseline to End of Follow up 6 1
Completed 6 1
Not Completed 36 21
Reason Not Completed
Lack of Efficacy             34             18
Withdrawal by Subject             2             3
Arm/Group Title NTZ+PR Placebo+PR Total
Hide Arm/Group Description

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 42 22 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  92.9%
21
  95.5%
60
  93.8%
>=65 years
3
   7.1%
1
   4.5%
4
   6.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 22 participants 64 participants
54  (8) 53  (6) 53.5  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
Female
13
  31.0%
8
  36.4%
21
  32.8%
Male
29
  69.0%
14
  63.6%
43
  67.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 22 participants 64 participants
42 22 64
1.Primary Outcome
Title Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)
Hide Description Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection 24 weeks after the end of treatment. All others were considered non-responders.
Time Frame 24 weeks after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 42 22
Measure Type: Number
Unit of Measure: participants
Responders 3 0
Non-responders 39 22
2.Secondary Outcome
Title End of Treatment Response (HCV RNA Below Lower Limit of Detection)
Hide Description Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection at the end of treatment. All others were considered non-responders.
Time Frame At end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 42 22
Measure Type: Number
Unit of Measure: participants
Responders 6 1
Non-responders 36 21
3.Secondary Outcome
Title Early Virologic Response (HCV RNA Below Lower Limit of Detection)
Hide Description Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 12 weeks of combination therapy.
Time Frame After 12 weeks combination treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 42 22
Measure Type: Number
Unit of Measure: participants
Responders 3 0
Non-responders 39 22
4.Secondary Outcome
Title Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)
Hide Description Hepatitis C Virus Ribonucleic Acid (HCV RNA) below lower limit of detection after 4 weeks of combination therapy.
Time Frame After 4 weeks combination treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 42 22
Measure Type: Number
Unit of Measure: participants
Responders 2 0
Non-responders 40 22
5.Secondary Outcome
Title Changes in ALT
Hide Description This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Time Frame From baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 31 20
Measure Type: Number
Unit of Measure: participants
Remains Elevated 14 8
Elevated to Normal 7 2
Remains Normal 9 9
Normal to Elevated 1 1
6.Secondary Outcome
Title Changes in ALT
Hide Description This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Time Frame From baseline to week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 24 11
Measure Type: Number
Unit of Measure: participants
Remains Elevated 6 2
Elevated to Normal 6 2
Remains Normal 12 6
Normal to Elevated 0 1
7.Secondary Outcome
Title Changes in ALT
Hide Description This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Time Frame From baseline to end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 6 1
Measure Type: Number
Unit of Measure: participants
Remains Elevated 0 0
Elevated to Normal 1 0
Remains Normal 5 1
Normal to Elevated 0 0
8.Secondary Outcome
Title Changes in ALT
Hide Description This analysis was conducted using a comparison of changes in Alanine aminotransferase (ALT) from baseline through week 8, week 16, end of treatment and end of follow up.
Time Frame From baseline to end of follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description:

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Overall Number of Participants Analyzed 6 1
Measure Type: Number
Unit of Measure: participants
Remains Elevated 0 0
Elevated to Normal 1 0
Remains Normal 4 1
Normal to Elevated 1 0
Time Frame 2 years, 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NTZ+PR Placebo+PR
Hide Arm/Group Description

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

All-Cause Mortality
NTZ+PR Placebo+PR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NTZ+PR Placebo+PR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/42 (2.38%)      1/22 (4.55%)    
Renal and urinary disorders     
Pyelonephritis  1  1/42 (2.38%)  1 0/22 (0.00%)  0
Kidney Calculus  1  1/42 (2.38%)  1 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Edema Larynx  1  0/42 (0.00%)  0 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NTZ+PR Placebo+PR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/42 (100.00%)      20/22 (90.91%)    
Blood and lymphatic system disorders     
Leukopenia  1  20/42 (47.62%)  20 8/22 (36.36%)  8
Thrombocytopenia  1  12/42 (28.57%)  12 3/22 (13.64%)  3
Anemia  1  11/42 (26.19%)  11 5/22 (22.73%)  5
Gastrointestinal disorders     
Pain Abdo  1  9/42 (21.43%)  9 2/22 (9.09%)  2
Diarrhea  1  17/42 (40.48%)  17 3/22 (13.64%)  3
Nausea  1  10/42 (23.81%)  10 4/22 (18.18%)  4
Anorexia  1  6/42 (14.29%)  6 1/22 (4.55%)  1
Constip  1  5/42 (11.90%)  5 2/22 (9.09%)  2
Liver Func Abnorm  1  4/42 (9.52%)  4 1/22 (4.55%)  1
Dry Mouth  1  1/42 (2.38%)  1 3/22 (13.64%)  3
General disorders     
Asthenia  1  23/42 (54.76%)  23 10/22 (45.45%)  10
Headache  1  9/42 (21.43%)  9 6/22 (27.27%)  6
Pain Back  1  6/42 (14.29%)  6 0/22 (0.00%)  0
Flu Synd  1  5/42 (11.90%)  5 2/22 (9.09%)  2
Metabolism and nutrition disorders     
Albuminuria  1  6/42 (14.29%)  6 3/22 (13.64%)  3
Musculoskeletal and connective tissue disorders     
Myalgia  1  7/42 (16.67%)  7 2/22 (9.09%)  2
Arthralgia  1  4/42 (9.52%)  4 0/22 (0.00%)  0
Cramps Leg  1  4/42 (9.52%)  4 0/22 (0.00%)  0
Nervous system disorders     
Agitation  1  12/42 (28.57%)  12 6/22 (27.27%)  6
Depression  1  8/42 (19.05%)  8 5/22 (22.73%)  5
Insomnia  1  8/42 (19.05%)  8 4/22 (18.18%)  4
Anxiety  1  1/42 (2.38%)  1 4/22 (18.18%)  4
Dizziness  1  7/42 (16.67%)  7 3/22 (13.64%)  3
Renal and urinary disorders     
Polyuria  1  5/42 (11.90%)  5 2/22 (9.09%)  2
Respiratory, thoracic and mediastinal disorders     
Pharyngitis  1  6/42 (14.29%)  6 1/22 (4.55%)  1
Rhinitis  1  4/42 (9.52%)  4 3/22 (13.64%)  3
Dyspnea  1  3/42 (7.14%)  3 3/22 (13.64%)  3
Cough Inc  1  3/42 (7.14%)  3 3/22 (13.64%)  3
Skin and subcutaneous tissue disorders     
Rash  1  9/42 (21.43%)  9 5/22 (22.73%)  5
Skin Dry  1  7/42 (16.67%)  7 2/22 (9.09%)  2
Pruritus  1  5/42 (11.90%)  5 2/22 (9.09%)  2
Alopecia  1  4/42 (9.52%)  4 3/22 (13.64%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
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.
Presentation and/or publication is encouraged provided the Sponsor is notified in advance and given the opportunity to review the manuscript or abstract 30 days prior to its submission for presentation at a scientific meeting or for publication in a scientific journal. The investigators will have complete autonomy regarding the content and wording including the decision of whether or not to publish.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marc Ayers
Organization: Romark Laboratories, L.C.
Phone: 813-282-8544
EMail: Marc.Ayers@romark.com
Layout table for additonal information
Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT00495391     History of Changes
Other Study ID Numbers: RM01-2025
First Submitted: July 2, 2007
First Posted: July 3, 2007
Results First Submitted: November 18, 2013
Results First Posted: January 6, 2014
Last Update Posted: May 8, 2014