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Trial record 11 of 31 for:    " February 14, 2007":" March 16, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC

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ClinicalTrials.gov Identifier: NCT00440271
Recruitment Status : Terminated
First Posted : February 27, 2007
Results First Posted : November 26, 2009
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: tipranavir
Drug: ritonavir
Drug: Optimized Background Regimen (OBR)
Enrollment 33

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted. Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Period Title: Overall Study
Started 15 18
Completed 3 3
Not Completed 12 15
Reason Not Completed
Protocol Violation             1             1
Adverse Event             0             1
Lost to Follow-up             1             0
Withdrawal by Subject             0             2
Lack of Efficacy             0             1
Due to closure of trial             8             10
Other             2             0
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM) Total
Hide Arm/Group Description Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted. Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations. Total of all reporting groups
Overall Number of Baseline Participants 15 18 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 18 participants 33 participants
46.1  (8.2) 43.2  (10.6) 44.5  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 18 participants 33 participants
Female
3
  20.0%
6
  33.3%
9
  27.3%
Male
12
  80.0%
12
  66.7%
24
  72.7%
1.Primary Outcome
Title Treatment Response at Week 48
Hide Description percentage of participants whose viral load <50 copies/mL at Week 48
Time Frame after 48 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Participants Whose ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Viral Load From Baseline at Each Visit
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Treatment Failure
Hide Description For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.
Time Frame after Day 1 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Time to New AIDS or AIDS Related Progression Event or Death
Hide Description [Not Specified]
Time Frame after Day 1 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change in Ratio of CD38+/CD8+ From Baseline to Week 48
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Patients Adherence With Study Medication Based on Pill Count
Hide Description [Not Specified]
Time Frame after 4 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Occurrence of TPV Trough Concentration >120 μM
Hide Description [Not Specified]
Time Frame after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Post-dose TPV and RTV Concentrations at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description:
Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 48 weeks of treatment plus 30 days follow-up
Adverse Event Reporting Description MedDra 11.1 WHO-DD 08SEP
 
Arm/Group Title Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Hide Arm/Group Description Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted. Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
All-Cause Mortality
Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
Affected / at Risk (%) Affected / at Risk (%)
Total   12/15 (80.00%)   15/18 (83.33%) 
Ear and labyrinth disorders     
Tinnitus  1  1/15 (6.67%)  0/18 (0.00%) 
Eye disorders     
Eye discharge  1  1/15 (6.67%)  0/18 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/15 (0.00%)  1/18 (5.56%) 
Colonic polyp  1  1/15 (6.67%)  0/18 (0.00%) 
Diarrhoea  1  5/15 (33.33%)  3/18 (16.67%) 
Dyspepsia  1  0/15 (0.00%)  1/18 (5.56%) 
Flatulence  1  1/15 (6.67%)  0/18 (0.00%) 
Haemorrhoids  1  1/15 (6.67%)  0/18 (0.00%) 
Nausea  1  2/15 (13.33%)  1/18 (5.56%) 
Rectal haemorrhage  1  1/15 (6.67%)  0/18 (0.00%) 
Vomiting  1  1/15 (6.67%)  4/18 (22.22%) 
General disorders     
Adverse drug reaction  1  1/15 (6.67%)  0/18 (0.00%) 
Fatigue  1  3/15 (20.00%)  0/18 (0.00%) 
Feeling abnormal  1  1/15 (6.67%)  0/18 (0.00%) 
Pyrexia  1  1/15 (6.67%)  0/18 (0.00%) 
Infections and infestations     
Bronchitis  1  1/15 (6.67%)  0/18 (0.00%) 
Conjunctivitis infective  1  1/15 (6.67%)  0/18 (0.00%) 
Gastroenteritis  1  0/15 (0.00%)  1/18 (5.56%) 
Genital herpes  1  0/15 (0.00%)  1/18 (5.56%) 
Infection  1  1/15 (6.67%)  0/18 (0.00%) 
Nasopharyngitis  1  0/15 (0.00%)  1/18 (5.56%) 
Oral candidiasis  1  1/15 (6.67%)  0/18 (0.00%) 
Oropharyngeal candidiasis  1  0/15 (0.00%)  1/18 (5.56%) 
Rash pustular  1  0/15 (0.00%)  1/18 (5.56%) 
Sinusitis  1  1/15 (6.67%)  0/18 (0.00%) 
Upper respiratory tract infection  1  1/15 (6.67%)  0/18 (0.00%) 
Vaginal infection  1  0/15 (0.00%)  1/18 (5.56%) 
Investigations     
Blood amylase increased  1  1/15 (6.67%)  0/18 (0.00%) 
Blood cholesterol increased  1  1/15 (6.67%)  0/18 (0.00%) 
Blood triglycerides increased  1  1/15 (6.67%)  2/18 (11.11%) 
Gamma-glutamyltransferase increased  1  1/15 (6.67%)  0/18 (0.00%) 
Lipase increased  1  1/15 (6.67%)  0/18 (0.00%) 
Metabolism and nutrition disorders     
Dyslipidaemia  1  1/15 (6.67%)  0/18 (0.00%) 
Hypertriglyceridaemia  1  1/15 (6.67%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/15 (6.67%)  0/18 (0.00%) 
Arthritis  1  1/15 (6.67%)  0/18 (0.00%) 
Back pain  1  1/15 (6.67%)  1/18 (5.56%) 
Groin pain  1  1/15 (6.67%)  0/18 (0.00%) 
Muscle spasms  1  2/15 (13.33%)  0/18 (0.00%) 
Musculoskeletal pain  1  1/15 (6.67%)  0/18 (0.00%) 
Pain in extremity  1  2/15 (13.33%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Melanocytic naevus  1  1/15 (6.67%)  0/18 (0.00%) 
Nervous system disorders     
Dizziness  1  0/15 (0.00%)  2/18 (11.11%) 
Headache  1  1/15 (6.67%)  1/18 (5.56%) 
Psychiatric disorders     
Depression  1  0/15 (0.00%)  1/18 (5.56%) 
Nightmare  1  1/15 (6.67%)  1/18 (5.56%) 
Sleep disorder  1  0/15 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/15 (0.00%)  1/18 (5.56%) 
Nasal congestion  1  0/15 (0.00%)  1/18 (5.56%) 
Oropharyngeal pain  1  0/15 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders     
Erythema nodosum  1  1/15 (6.67%)  0/18 (0.00%) 
Heat rash  1  0/15 (0.00%)  1/18 (5.56%) 
Night sweats  1  1/15 (6.67%)  0/18 (0.00%) 
Pruritus generalised  1  1/15 (6.67%)  0/18 (0.00%) 
Rash  1  2/15 (13.33%)  1/18 (5.56%) 
Rash maculo-papular  1  0/15 (0.00%)  1/18 (5.56%) 
Subcutaneous nodule  1  1/15 (6.67%)  0/18 (0.00%) 
Vitiligo  1  1/15 (6.67%)  0/18 (0.00%) 
Vascular disorders     
Hot flush  1  1/15 (6.67%)  0/18 (0.00%) 
Hypertension  1  1/15 (6.67%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00440271     History of Changes
Other Study ID Numbers: 1182.98
EudraCT No.: 2005-005264-86
First Submitted: February 26, 2007
First Posted: February 27, 2007
Results First Submitted: October 20, 2009
Results First Posted: November 26, 2009
Last Update Posted: June 27, 2014