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Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)

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ClinicalTrials.gov Identifier: NCT00991939
Recruitment Status : Terminated (The study was closed due to accrual futility there were only a total of 8 subjects enrolled.)
First Posted : October 8, 2009
Results First Posted : February 14, 2014
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Immune Thrombocytopenic Purpura
Interventions Drug: Dexamethasone USP Micronized
Drug: Prednisone
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules. Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Period Title: Overall Study
Started 5 3
Completed 0 1
Not Completed 5 2
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             1             0
Entire study terminated             4             1
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy Total
Hide Arm/Group Description Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules. Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding. Total of all reporting groups
Overall Number of Baseline Participants 5 3 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
1
  33.3%
6
  75.0%
>=65 years
0
   0.0%
2
  66.7%
2
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 8 participants
37.2  (15.6) 62.5  (35.8) 46.7  (26.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 8 participants
Female
3
  60.0%
1
  33.3%
4
  50.0%
Male
2
  40.0%
2
  66.7%
4
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 3 participants 8 participants
5 3 8
1.Primary Outcome
Title The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.
Hide Description [Not Specified]
Time Frame From 60 days through 365 days after study entry.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 3 1
Measure Type: Number
Unit of Measure: percentage of subjects
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Pulse Dexamethasone, Standard Prednisone Therapy
Comments Four subjects were not included in this analysis because not enough data was available to assess the primary outcome at the time the study was terminated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of proportions
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.975 to 0.708
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.58
Estimation Comments The estimated value is the proportion of success in the high dose pulse dexamethasone group minus the proportion of success in the standard prednisone group.
2.Secondary Outcome
Title The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry
Hide Description [Not Specified]
Time Frame From 60 days through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365
Hide Description [Not Specified]
Time Frame 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry
Hide Description [Not Specified]
Time Frame From 180 days through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry
Hide Description [Not Specified]
Time Frame From 180 days through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry
Hide Description [Not Specified]
Time Frame Through 60 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry
Hide Description [Not Specified]
Time Frame From 60 days through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)
Hide Description [Not Specified]
Time Frame From 60 days through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)
Hide Description [Not Specified]
Time Frame From 60 days through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title The Percentage of Patients Undergoing Splenectomy
Hide Description [Not Specified]
Time Frame Through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey
Hide Description [Not Specified]
Time Frame Weeks 4, 8, and 52 after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score
Hide Description [Not Specified]
Time Frame Through 365 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title The Percentage of Patients Not Completing Study Therapy
Hide Description [Not Specified]
Time Frame 49 days after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy
Hide Description [Not Specified]
Time Frame Through 1 year after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description:
Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Pulse Dexamethasone Standard Prednisone Therapy
Hide Arm/Group Description Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules. Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
All-Cause Mortality
High Dose Pulse Dexamethasone Standard Prednisone Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Pulse Dexamethasone Standard Prednisone Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      1/3 (33.33%)    
Blood and lymphatic system disorders     
Thrombocytopenia  2/5 (40.00%)  2 0/3 (0.00%)  0
Gastrointestinal disorders     
Gingival bleeding  1/5 (20.00%)  1 0/3 (0.00%)  0
General disorders     
Adverse drug reaction  1/5 (20.00%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications     
Laceration  0/5 (0.00%)  0 1/3 (33.33%)  1
Tibia fracture  0/5 (0.00%)  0 1/3 (33.33%)  1
Investigations     
Occult blood  1/5 (20.00%)  1 0/3 (0.00%)  0
Nervous system disorders     
Headache  1/5 (20.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1/5 (20.00%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Increased tendency to bruise  1/5 (20.00%)  1 0/3 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose Pulse Dexamethasone Standard Prednisone Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Anaemia vitamin B12 deficiency  1/5 (20.00%)  1 0/3 (0.00%)  0
Cardiac disorders     
Palpitations  3/5 (60.00%)  5 0/3 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1/5 (20.00%)  1 0/3 (0.00%)  0
Endocrine disorders     
Cushingoid  1/5 (20.00%)  1 1/3 (33.33%)  2
Eye disorders     
Conjunctival haemorrhage  1/5 (20.00%)  1 1/3 (33.33%)  1
Eye pain  1/5 (20.00%)  1 0/3 (0.00%)  0
Scleral haemorrhage  0/5 (0.00%)  0 1/3 (33.33%)  1
Vision blurred  5/5 (100.00%)  6 0/3 (0.00%)  0
Visual acuity reduced  1/5 (20.00%)  1 0/3 (0.00%)  0
Visual impairment  0/5 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders     
Abdominal pain  1/5 (20.00%)  1 1/3 (33.33%)  1
Anal haemorrhage  0/5 (0.00%)  0 1/3 (33.33%)  1
Diarrhoea  2/5 (40.00%)  2 0/3 (0.00%)  0
Gingival bleeding  0/5 (0.00%)  0 1/3 (33.33%)  1
Haemorrhoids  1/5 (20.00%)  1 0/3 (0.00%)  0
Mouth haemorrhage  2/5 (40.00%)  3 0/3 (0.00%)  0
Mouth ulceration  2/5 (40.00%)  2 0/3 (0.00%)  0
Nausea  2/5 (40.00%)  3 2/3 (66.67%)  3
Oral disorder  0/5 (0.00%)  0 1/3 (33.33%)  1
Vomiting  3/5 (60.00%)  3 0/3 (0.00%)  0
Dyspepsia  1/5 (20.00%)  1 0/3 (0.00%)  0
General disorders     
Application site bleeding  1/5 (20.00%)  1 0/3 (0.00%)  0
Chest pain  3/5 (60.00%)  4 1/3 (33.33%)  1
Face oedema  1/5 (20.00%)  2 1/3 (33.33%)  2
Fat tissue increased  1/5 (20.00%)  1 2/3 (66.67%)  2
Fatigue  5/5 (100.00%)  8 3/3 (100.00%)  3
Feeling jittery  1/5 (20.00%)  1 0/3 (0.00%)  0
Malaise  1/5 (20.00%)  1 0/3 (0.00%)  0
Mucosal haemorrhage  1/5 (20.00%)  2 0/3 (0.00%)  0
Non-cardiac chest pain  1/5 (20.00%)  1 0/3 (0.00%)  0
Oedema  1/5 (20.00%)  1 0/3 (0.00%)  0
Pyrexia  1/5 (20.00%)  1 0/3 (0.00%)  0
Swelling  1/5 (20.00%)  1 0/3 (0.00%)  0
Thirst  4/5 (80.00%)  5 2/3 (66.67%)  3
Infections and infestations     
Bronchitis  1/5 (20.00%)  3 0/3 (0.00%)  0
Influenza  1/5 (20.00%)  1 0/3 (0.00%)  0
Pharyngitis  1/5 (20.00%)  1 0/3 (0.00%)  0
Viral upper respiratory tract  0/5 (0.00%)  0 1/3 (33.33%)  1
Paronychia  1/5 (20.00%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications     
Compensatory sweating  1/5 (20.00%)  1 1/3 (33.33%)  1
Investigations     
Occult blood  1/5 (20.00%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Abnormal weight gain  0/5 (0.00%)  0 1/3 (33.33%)  1
Appetite disorder  1/5 (20.00%)  1 0/3 (0.00%)  0
Dehydration  1/5 (20.00%)  2 0/3 (0.00%)  0
Increased appetite  4/5 (80.00%)  7 3/3 (100.00%)  3
Weight fluctuation  1/5 (20.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  3/5 (60.00%)  4 3/3 (100.00%)  4
Bone pain  0/5 (0.00%)  0 1/3 (33.33%)  2
Joint swelling  1/5 (20.00%)  1 1/3 (33.33%)  4
Muscular weakness  2/5 (40.00%)  2 2/3 (66.67%)  2
Pain in extremity  1/5 (20.00%)  1 0/3 (0.00%)  0
Nervous system disorders     
Dizziness  1/5 (20.00%)  1 1/3 (33.33%)  1
Headache  2/5 (40.00%)  2 1/3 (33.33%)  1
Migraine  1/5 (20.00%)  1 0/3 (0.00%)  0
Poor quality sleep  2/5 (40.00%)  3 1/3 (33.33%)  1
Syncope  0/5 (0.00%)  0 1/3 (33.33%)  1
Tremor  1/5 (20.00%)  1 2/3 (66.67%)  3
Psychiatric disorders     
Agitation  1/5 (20.00%)  2 0/3 (0.00%)  0
Anxiety  5/5 (100.00%)  8 2/3 (66.67%)  2
Depressed mood  1/5 (20.00%)  1 1/3 (33.33%)  1
Depression  2/5 (40.00%)  2 1/3 (33.33%)  1
Insomnia  3/5 (60.00%)  4 1/3 (33.33%)  1
Libido decreased  1/5 (20.00%)  1 0/3 (0.00%)  0
Mood swings  3/5 (60.00%)  5 2/3 (66.67%)  2
Nightmare  2/5 (40.00%)  2 2/3 (66.67%)  2
Restlessness  4/5 (80.00%)  4 2/3 (66.67%)  3
Renal and urinary disorders     
Haematuria  1/5 (20.00%)  1 0/3 (0.00%)  0
Reproductive system and breast disorders     
Breast enlargement  1/5 (20.00%)  1 0/3 (0.00%)  0
Male sexual dysfunction  0/5 (0.00%)  0 2/3 (66.67%)  2
Menorrhagia  1/5 (20.00%)  4 0/3 (0.00%)  0
Menstruation irregular  1/5 (20.00%)  3 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  0/5 (0.00%)  0 1/3 (33.33%)  1
Dyspnoea  1/5 (20.00%)  1 0/3 (0.00%)  0
Epistaxis  3/5 (60.00%)  4 2/3 (66.67%)  3
Haemoptysis  1/5 (20.00%)  1 0/3 (0.00%)  0
Nasal congestion  1/5 (20.00%)  1 0/3 (0.00%)  0
Pulmonary congestion  1/5 (20.00%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1/5 (20.00%)  1 1/3 (33.33%)  1
Blood blister  0/5 (0.00%)  0 2/3 (66.67%)  2
Dermatitis acneiform  1/5 (20.00%)  1 0/3 (0.00%)  0
Dry skin  5/5 (100.00%)  6 2/3 (66.67%)  3
Ecchymosis  0/5 (0.00%)  0 1/3 (33.33%)  3
Erythema  1/5 (20.00%)  1 1/3 (33.33%)  1
Hyperhidrosis  4/5 (80.00%)  6 0/3 (0.00%)  0
Increased tendency to bruise  5/5 (100.00%)  10 2/3 (66.67%)  4
Nail discomfort  0/5 (0.00%)  0 1/3 (33.33%)  2
Night sweats  0/5 (0.00%)  0 1/3 (33.33%)  3
Oil acne  1/5 (20.00%)  1 0/3 (0.00%)  0
Onycholysis  1/5 (20.00%)  1 0/3 (0.00%)  0
Petechiae  3/5 (60.00%)  4 2/3 (66.67%)  2
Rash  1/5 (20.00%)  1 1/3 (33.33%)  1
Seborrhoea  1/5 (20.00%)  1 0/3 (0.00%)  0
Skin discolouration  0/5 (0.00%)  0 1/3 (33.33%)  1
Skin disorder  0/5 (0.00%)  0 1/3 (33.33%)  1
Skin reaction  0/5 (0.00%)  0 1/3 (33.33%)  1
Swelling face  0/5 (0.00%)  0 1/3 (33.33%)  2
Urticaria  0/5 (0.00%)  0 1/3 (33.33%)  1
Skin discomfort  0/5 (0.00%)  0 1/3 (33.33%)  1
Surgical and medical procedures     
Menstrual cycle management  1/5 (20.00%)  1 0/3 (0.00%)  0
Vascular disorders     
Flushing  2/5 (40.00%)  2 2/3 (66.67%)  2
Hypertension  0/5 (0.00%)  0 1/3 (33.33%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan F. Assmann, PhD
Organization: New England Research Institutes, Inc.
Phone: 617-923-7747 ext 548
EMail: sassmann@neriscience.com
Layout table for additonal information
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00991939     History of Changes
Other Study ID Numbers: 675
U01HL072268 ( U.S. NIH Grant/Contract )
HL072268
HL072033
HL072291
HL072196
HL072289
HL072248
HL072191
HL072299
HL072305
HL072274
HL072028
HL072359
HL072072
HL072355
HL072283
HL072346
HL072331
HL072290
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: January 2, 2014
Results First Posted: February 14, 2014
Last Update Posted: February 14, 2014