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Trial record 6 of 11 for:    pkc diabetes

Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00604383
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : January 28, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetic Retinopathy
Interventions Drug: ruboxistaurin
Drug: placebo
Enrollment 685
Recruitment Details  
Pre-assignment Details This study consisted of a 36-month treatment phase and a 0 to 6-month extended treatment phase. Completers are those who completed the 36-month treatment phase.
Arm/Group Title Ruboxistaurin Placebo
Hide Arm/Group Description One 32-milligram (mg) tablet, orally, daily, for up to 42 months 1 tablet, orally, daily, for up to 42 months
Period Title: Overall Study
Started 345 340
Received at Least 1 Dose of Study Drug 345 340
Received Extended Treatment 136 141
Completed 258 256
Not Completed 87 84
Reason Not Completed
Withdrawal by Subject             33             31
Lost to Follow-up             24             19
Death             14             22
Adverse Event             16             9
Physician Decision             0             3
Arm/Group Title Ruboxistaurin Placebo Total
Hide Arm/Group Description One 32-mg tablet, orally, daily, for up to 42 months 1 tablet, orally, daily, for up to 42 months Total of all reporting groups
Overall Number of Baseline Participants 345 340 685
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 345 participants 340 participants 685 participants
59.48  (10.91) 59.18  (10.61) 59.33  (10.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants 340 participants 685 participants
Female
130
  37.7%
122
  35.9%
252
  36.8%
Male
215
  62.3%
218
  64.1%
433
  63.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 345 participants 340 participants 685 participants
African Descent 43 27 70
Caucasian 259 273 532
East/Southeast Asian 15 12 27
Hispanic 18 20 38
Other 9 8 17
Western Asian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 345 participants 340 participants 685 participants
345 340 685
1.Primary Outcome
Title Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period
Hide Description SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100.
Time Frame Baseline through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ruboxistaurin Placebo
Hide Arm/Group Description:
One 32-mg tablet, orally, daily, for 36 months
1 tablet, orally, daily, for 36 months
Overall Number of Participants Analyzed 345 340
Measure Type: Number
Unit of Measure: percentage of participants
5.5 9.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruboxistaurin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)
Hide Description DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100.
Time Frame Baseline through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had no center involved or imminently threatened DME at baseline.
Arm/Group Title Ruboxistaurin Placebo
Hide Arm/Group Description:
One 32-mg tablet, orally, daily, for 36 months
1 tablet, orally, daily, for 36 months
Overall Number of Participants Analyzed 248 249
Measure Type: Number
Unit of Measure: percentage of participants
44.4 49.0
3.Secondary Outcome
Title Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)
Hide Description Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100.
Time Frame Baseline through 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ruboxistaurin Placebo
Hide Arm/Group Description:
One 32-mg tablet, orally, daily, for 36 months
1 tablet, orally, daily, for 36 months
Overall Number of Participants Analyzed 345 340
Measure Type: Number
Unit of Measure: percentage of participants
35.9 36.5
4.Secondary Outcome
Title Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)
Hide Description NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome).
Time Frame Baseline, up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable NEI-VFQ-25 total score. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.
Arm/Group Title Ruboxistaurin Placebo
Hide Arm/Group Description:
One 32-mg tablet, orally, daily, for 36 months
1 tablet, orally, daily, for 36 months
Overall Number of Participants Analyzed 290 289
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.82  (14.75) -4.10  (13.45)
5.Secondary Outcome
Title Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire
Hide Description SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health.
Time Frame Baseline, up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with evaluable SF-36 MCS and PCS. LOCF was used to impute missing post-baseline values
Arm/Group Title Ruboxistaurin Placebo
Hide Arm/Group Description:
One 32-mg tablet, orally, daily, for 36 months
1 tablet, orally, daily, for 36 months
Overall Number of Participants Analyzed 290 289
Mean (Standard Deviation)
Unit of Measure: units on a scale
MCS -12.21  (70.91) -19.85  (70.05)
PCS -30.63  (84.92) -29.15  (79.41)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ruboxistaurin Placebo
Hide Arm/Group Description One 32-mg tablet, orally, daily, for up to 42 months 1 tablet, orally, daily, for up to 42 months
All-Cause Mortality
Ruboxistaurin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ruboxistaurin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   145/345 (42.03%)      157/340 (46.18%)    
Blood and lymphatic system disorders     
Anaemia  1  9/345 (2.61%)  10 13/340 (3.82%)  13
Hypersplenism  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Idiopathic thrombocytopenic purpura  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Lymphadenopathy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Normochromic normocytic anaemia  1  0/345 (0.00%)  0 1/340 (0.29%)  2
Pancytopenia  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Thrombocytopenia  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Cardiac disorders     
Acute coronary syndrome  1  2/345 (0.58%)  2 2/340 (0.59%)  2
Acute myocardial infarction  1  5/345 (1.45%)  5 6/340 (1.76%)  6
Angina pectoris  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Angina unstable  1  5/345 (1.45%)  6 4/340 (1.18%)  4
Aortic valve disease mixed  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Arrhythmia supraventricular  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Atrial fibrillation  1  5/345 (1.45%)  5 11/340 (3.24%)  11
Atrial flutter  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Atrioventricular block complete  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Atrioventricular block second degree  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Bradycardia  1  3/345 (0.87%)  3 1/340 (0.29%)  1
Cardiac arrest  1  2/345 (0.58%)  2 5/340 (1.47%)  5
Cardiac failure chronic  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Cardiac failure congestive  1  25/345 (7.25%)  38 19/340 (5.59%)  26
Cardio-respiratory arrest  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Cardiomyopathy  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Cor pulmonale chronic  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Coronary artery atherosclerosis  1  1/345 (0.29%)  1 1/340 (0.29%)  2
Coronary artery disease  1  30/345 (8.70%)  38 30/340 (8.82%)  33
Coronary artery insufficiency  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Coronary artery occlusion  1  1/345 (0.29%)  1 3/340 (0.88%)  3
Hypertensive cardiomyopathy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Ischaemic cardiomyopathy  1  1/345 (0.29%)  1 2/340 (0.59%)  2
Mitral valve incompetence  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Myocardial infarction  1  4/345 (1.16%)  4 13/340 (3.82%)  16
Pericardial effusion  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Pericarditis  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Right ventricular failure  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Sick sinus syndrome  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Sinus bradycardia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Tachycardia  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Torsade de pointes  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Tricuspid valve incompetence  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Ventricular tachycardia  1  2/345 (0.58%)  3 2/340 (0.59%)  2
Ear and labyrinth disorders     
Hearing impaired  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Inner ear disorder  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Vestibular neuronitis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Endocrine disorders     
Hyperthyroidism  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Eye disorders     
Cataract  1  0/345 (0.00%)  0 1/340 (0.29%)  2
Endophthalmitis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Maculopathy  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Retinal artery occlusion  1  0/345 (0.00%)  0 1/340 (0.29%)  3
Retinal detachment  1  0/345 (0.00%)  0 4/340 (1.18%)  4
Retinal neovascularisation  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Retinal tear  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Retinal vein occlusion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Visual acuity reduced  1  0/345 (0.00%)  0 1/340 (0.29%)  3
Vitreous haemorrhage  1  1/345 (0.29%)  1 3/340 (0.88%)  5
Gastrointestinal disorders     
Abdominal pain  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Abdominal pain upper  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Abdominal strangulated hernia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Ascites  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Coeliac disease  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Colitis ischaemic  1  0/345 (0.00%)  0 2/340 (0.59%)  3
Colitis ulcerative  1  1/345 (0.29%)  1 1/340 (0.29%)  2
Colonic haemorrhage  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Diabetic gastroparesis  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Diarrhoea  1  0/345 (0.00%)  0 4/340 (1.18%)  4
Duodenal ulcer haemorrhage  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Duodenitis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Dysphagia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Gastric ulcer haemorrhage  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Gastritis  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Gastritis erosive  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Gastrointestinal haemorrhage  1  0/345 (0.00%)  0 3/340 (0.88%)  4
Gastrointestinal inflammation  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Gastrooesophageal reflux disease  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Haematochezia  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Haemorrhoids  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hypoaesthesia oral  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Ileus  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Intestinal obstruction  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Lower gastrointestinal haemorrhage  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Mallory-weiss syndrome  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Nausea  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Oesophagitis  1  1/345 (0.29%)  1 2/340 (0.59%)  2
Pancreatitis  1  3/345 (0.87%)  3 2/340 (0.59%)  2
Pancreatitis acute  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Peptic ulcer  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Small intestinal obstruction  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Umbilical hernia  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Uvulitis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Vomiting  1  1/345 (0.29%)  1 1/340 (0.29%)  1
General disorders     
Asthenia  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Chest pain  1  10/345 (2.90%)  12 4/340 (1.18%)  4
Death  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Generalised oedema  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Impaired healing  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Multi-organ failure  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Non-cardiac chest pain  1  4/345 (1.16%)  4 5/340 (1.47%)  6
Pyrexia  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Sudden death  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Cholecystitis acute  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Cholecystitis chronic  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Cholelithiasis  1  3/345 (0.87%)  3 5/340 (1.47%)  5
Hepatic cirrhosis  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Hepatic failure  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hepatic steatosis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Portal hypertensive gastropathy  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Immune system disorders     
Allergy to arthropod sting  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Infections and infestations     
Abdominal abscess  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Abdominal infection  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Abscess  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Abscess limb  1  2/345 (0.58%)  2 3/340 (0.88%)  3
Abscess neck  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Acute tonsillitis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Appendicitis  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Bacteraemia  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Bronchitis  1  1/345 (0.29%)  1 2/340 (0.59%)  2
Bronchitis acute  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Cellulitis  1  12/345 (3.48%)  16 12/340 (3.53%)  13
Clostridium colitis  1  4/345 (1.16%)  4 2/340 (0.59%)  2
Cystitis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Diabetic foot infection  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Diarrhoea infectious  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Diverticulitis  1  3/345 (0.87%)  3 0/340 (0.00%)  0
Endocarditis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Enterococcal infection  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Fungal cystitis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Gangrene  1  2/345 (0.58%)  2 3/340 (0.88%)  4
Gastroenteritis  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Gastroenteritis viral  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Gastrointestinal infection  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Herpes zoster  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Influenza  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Localised infection  1  2/345 (0.58%)  2 2/340 (0.59%)  2
Mastoiditis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Meningitis viral  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Necrotising fasciitis  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Oesophageal candidiasis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Osteomyelitis  1  8/345 (2.32%)  9 6/340 (1.76%)  9
Otitis externa  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Paronychia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Parotitis  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Perirectal abscess  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Pneumonia  1  14/345 (4.06%)  15 13/340 (3.82%)  15
Post procedural cellulitis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Postoperative infection  1  1/345 (0.29%)  1 3/340 (0.88%)  3
Pseudomonas infection  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Pyelonephritis  1  3/345 (0.87%)  3 2/340 (0.59%)  2
Sepsis  1  4/345 (1.16%)  4 4/340 (1.18%)  4
Septic embolus  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Sinusitis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Staphylococcal bacteraemia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Staphylococcal infection  1  2/345 (0.58%)  2 2/340 (0.59%)  3
Staphylococcal sepsis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Streptococcal bacteraemia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Urinary tract infection  1  2/345 (0.58%)  2 5/340 (1.47%)  5
Urinary tract infection enterococcal  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Urosepsis  1  1/345 (0.29%)  1 4/340 (1.18%)  5
Wound infection  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Wound infection staphylococcal  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Brain contusion  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Chemical burn of skin  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Clavicle fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Closed head injury  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Contusion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Dislocation of joint prosthesis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Drug toxicity  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Facial bones fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Fall  1  6/345 (1.74%)  6 5/340 (1.47%)  5
Femoral neck fracture  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Femur fracture  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Fibula fracture  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Foot fracture  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Forearm fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Haemothorax  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Head injury  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Hip fracture  1  1/345 (0.29%)  1 4/340 (1.18%)  4
Humerus fracture  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Joint dislocation  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Lower limb fracture  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Lung injury  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Meniscus lesion  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Patella fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Post procedural haematoma  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Post procedural haemorrhage  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Procedural hypertension  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Radius fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Rib fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Road traffic accident  1  1/345 (0.29%)  1 4/340 (1.18%)  4
Scapula fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Shunt occlusion  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Skin laceration  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Subdural haematoma  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Therapeutic agent toxicity  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Ulna fracture  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Vascular graft occlusion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Wound dehiscence  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Investigations     
Blood glucose fluctuation  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Blood glucose increased  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Blood potassium increased  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Coagulation time abnormal  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Electrocardiogram qt prolonged  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Weight decreased  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Dehydration  1  2/345 (0.58%)  3 7/340 (2.06%)  9
Diabetes mellitus inadequate control  1  2/345 (0.58%)  4 1/340 (0.29%)  1
Diabetic foot  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Diabetic ketoacidosis  1  2/345 (0.58%)  2 3/340 (0.88%)  4
Fluid overload  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Gout  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hypercalcaemia  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hyperglycaemia  1  2/345 (0.58%)  3 1/340 (0.29%)  1
Hyperkalaemia  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Hypoglycaemia  1  4/345 (1.16%)  4 3/340 (0.88%)  3
Hypovolaemia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Ketoacidosis  1  1/345 (0.29%)  3 0/340 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Arthropathy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Chest wall pain  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Intervertebral disc disorder  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Intervertebral disc protrusion  1  2/345 (0.58%)  2 2/340 (0.59%)  2
Lower limb deformity  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Lumbar spinal stenosis  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Monarthritis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Myositis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Neuropathic arthropathy  1  2/345 (0.58%)  3 2/340 (0.59%)  2
Osteoarthritis  1  3/345 (0.87%)  3 3/340 (0.88%)  3
Pain in extremity  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Pathological fracture  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Rotator cuff syndrome  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Spinal column stenosis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Spinal osteoarthritis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Tenosynovitis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Bladder cancer recurrent  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Breast cancer in situ  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Colon cancer  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Endometrial cancer  1  0/130 (0.00%)  0 1/122 (0.82%)  1
Gastric cancer  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Malignant melanoma  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Malignant pleural effusion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Metastases to bone  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Metastases to lymph nodes  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Metastases to pleura  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Metastatic malignant melanoma  1  2/345 (0.58%)  4 0/340 (0.00%)  0
Neoplasm malignant  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Non-small cell lung cancer  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Oesophageal adenocarcinoma metastatic  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Pancreatic carcinoma metastatic  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Prostate cancer  1  0/215 (0.00%)  0 1/218 (0.46%)  1
Renal cell carcinoma stage unspecified  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Spinal meningioma benign  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Squamous endometrial carcinoma  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Nervous system disorders     
Anoxic encephalopathy  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Carotid artery occlusion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Carotid artery stenosis  1  3/345 (0.87%)  3 2/340 (0.59%)  2
Cerebellar haemorrhage  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Cerebral artery occlusion  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Cerebrovascular accident  1  5/345 (1.45%)  5 8/340 (2.35%)  9
Cognitive disorder  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Convulsion  1  1/345 (0.29%)  1 2/340 (0.59%)  2
Dementia  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Demyelinating polyneuropathy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Diabetic neuropathy  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Dizziness  1  1/345 (0.29%)  1 4/340 (1.18%)  5
Embolic stroke  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Encephalopathy  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Facial palsy  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Haemorrhage intracranial  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hemiparesis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hepatic encephalopathy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Intracranial aneurysm  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Intraventricular haemorrhage  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Loss of consciousness  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Migraine  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Neuropathy peripheral  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Paraesthesia  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Radiculopathy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Subarachnoid haemorrhage  1  3/345 (0.87%)  3 0/340 (0.00%)  0
Syncope  1  4/345 (1.16%)  5 7/340 (2.06%)  8
Syncope vasovagal  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Transient ischaemic attack  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Tremor  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Psychiatric disorders     
Confusional state  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Conversion disorder  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Delirium  1  1/345 (0.29%)  2 1/340 (0.29%)  1
Hallucination  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Major depression  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Mental status changes  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Psychotic disorder  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Renal and urinary disorders     
Azotaemia  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Bladder neck obstruction  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Nephrolithiasis  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Obstructive uropathy  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Renal artery stenosis  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Renal failure  1  3/345 (0.87%)  3 6/340 (1.76%)  6
Renal failure acute  1  14/345 (4.06%)  18 12/340 (3.53%)  12
Renal failure chronic  1  9/345 (2.61%)  12 5/340 (1.47%)  6
Renal tubular necrosis  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Urinary retention  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/215 (0.47%)  1 0/218 (0.00%)  0
Priapism  1  0/215 (0.00%)  0 1/218 (0.46%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Acute respiratory failure  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Asthma  1  2/345 (0.58%)  3 1/340 (0.29%)  1
Chronic obstructive airways disease exacerbated  1  0/345 (0.00%)  0 2/340 (0.59%)  3
Chronic obstructive pulmonary disease  1  3/345 (0.87%)  3 2/340 (0.59%)  2
Dyspnoea  1  3/345 (0.87%)  3 2/340 (0.59%)  2
Hydrothorax  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hypercapnia  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hypoxia  1  2/345 (0.58%)  2 0/340 (0.00%)  0
Obstructive airways disorder  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Pleural effusion  1  3/345 (0.87%)  5 3/340 (0.88%)  3
Pneumonia aspiration  1  0/345 (0.00%)  0 2/340 (0.59%)  2
Pneumonitis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Pneumothorax  1  0/345 (0.00%)  0 1/340 (0.29%)  2
Pulmonary embolism  1  2/345 (0.58%)  2 4/340 (1.18%)  4
Pulmonary hypertension  1  1/345 (0.29%)  1 2/340 (0.59%)  2
Pulmonary oedema  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Respiratory arrest  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Respiratory distress  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Respiratory failure  1  3/345 (0.87%)  3 3/340 (0.88%)  3
Restrictive pulmonary disease  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Sleep apnoea syndrome  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  0/345 (0.00%)  0 2/340 (0.59%)  3
Diabetic ulcer  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Skin ulcer  1  2/345 (0.58%)  3 7/340 (2.06%)  7
Surgical and medical procedures     
Cardiac pacemaker insertion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Carotid endarterectomy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Mastectomy  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Vascular disorders     
Aortic stenosis  1  1/345 (0.29%)  1 1/340 (0.29%)  1
Blood pressure inadequately controlled  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Deep vein thrombosis  1  3/345 (0.87%)  3 3/340 (0.88%)  4
Femoral artery occlusion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Haematoma  1  2/345 (0.58%)  2 1/340 (0.29%)  1
Hypertension  1  7/345 (2.03%)  8 8/340 (2.35%)  9
Hypertensive emergency  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Hypoperfusion  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Hypotension  1  4/345 (1.16%)  4 2/340 (0.59%)  2
Orthostatic hypotension  1  3/345 (0.87%)  4 3/340 (0.88%)  4
Peripheral embolism  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Peripheral occlusive disease  1  1/345 (0.29%)  1 0/340 (0.00%)  0
Peripheral vascular disorder  1  3/345 (0.87%)  3 3/340 (0.88%)  3
Shock  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Subclavian vein thrombosis  1  0/345 (0.00%)  0 1/340 (0.29%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ruboxistaurin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   314/345 (91.01%)      322/340 (94.71%)    
Blood and lymphatic system disorders     
Anaemia  1  30/345 (8.70%)  33 36/340 (10.59%)  37
Eye disorders     
Dry eye  1  17/345 (4.93%)  19 19/340 (5.59%)  21
Eye pain  1  22/345 (6.38%)  30 18/340 (5.29%)  28
Maculopathy  1  14/345 (4.06%)  19 17/340 (5.00%)  17
Vision blurred  1  18/345 (5.22%)  22 19/340 (5.59%)  26
Visual disturbance  1  19/345 (5.51%)  26 20/340 (5.88%)  26
Vitreous floaters  1  19/345 (5.51%)  26 15/340 (4.41%)  17
Vitreous haemorrhage  1  17/345 (4.93%)  20 20/340 (5.88%)  24
Gastrointestinal disorders     
Constipation  1  21/345 (6.09%)  24 21/340 (6.18%)  22
Diarrhoea  1  32/345 (9.28%)  37 40/340 (11.76%)  104
Dyspepsia  1  19/345 (5.51%)  22 12/340 (3.53%)  13
Gastrooesophageal reflux disease  1  27/345 (7.83%)  27 21/340 (6.18%)  21
Nausea  1  26/345 (7.54%)  33 37/340 (10.88%)  46
Vomiting  1  20/345 (5.80%)  24 33/340 (9.71%)  56
General disorders     
Asthenia  1  18/345 (5.22%)  30 17/340 (5.00%)  19
Chest pain  1  17/345 (4.93%)  24 22/340 (6.47%)  32
Fatigue  1  19/345 (5.51%)  23 19/340 (5.59%)  21
Oedema peripheral  1  61/345 (17.68%)  73 67/340 (19.71%)  99
Pyrexia  1  19/345 (5.51%)  26 16/340 (4.71%)  20
Infections and infestations     
Bronchitis  1  24/345 (6.96%)  30 29/340 (8.53%)  38
Influenza  1  44/345 (12.75%)  55 45/340 (13.24%)  49
Localised infection  1  21/345 (6.09%)  29 22/340 (6.47%)  29
Nasopharyngitis  1  59/345 (17.10%)  91 67/340 (19.71%)  112
Onychomycosis  1  18/345 (5.22%)  19 18/340 (5.29%)  19
Pneumonia  1  11/345 (3.19%)  12 17/340 (5.00%)  19
Sinusitis  1  25/345 (7.25%)  38 32/340 (9.41%)  43
Upper respiratory tract infection  1  23/345 (6.67%)  29 35/340 (10.29%)  51
Urinary tract infection  1  25/345 (7.25%)  33 31/340 (9.12%)  44
Injury, poisoning and procedural complications     
Contusion  1  12/345 (3.48%)  19 23/340 (6.76%)  26
Fall  1  18/345 (5.22%)  19 17/340 (5.00%)  23
Investigations     
Blood cholesterol increased  1  25/345 (7.25%)  25 16/340 (4.71%)  16
Cardiac murmur  1  26/345 (7.54%)  26 21/340 (6.18%)  22
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  30/345 (8.70%)  30 28/340 (8.24%)  28
Obesity  1  14/345 (4.06%)  14 18/340 (5.29%)  18
Musculoskeletal and connective tissue disorders     
Arthralgia  1  24/345 (6.96%)  29 36/340 (10.59%)  44
Arthritis  1  8/345 (2.32%)  8 20/340 (5.88%)  23
Back pain  1  32/345 (9.28%)  36 27/340 (7.94%)  34
Joint swelling  1  27/345 (7.83%)  32 29/340 (8.53%)  39
Muscle spasms  1  11/345 (3.19%)  16 18/340 (5.29%)  19
Pain in extremity  1  38/345 (11.01%)  44 35/340 (10.29%)  50
Shoulder pain  1  18/345 (5.22%)  23 13/340 (3.82%)  15
Nervous system disorders     
Dizziness  1  29/345 (8.41%)  40 27/340 (7.94%)  30
Headache  1  33/345 (9.57%)  39 45/340 (13.24%)  59
Hypoaesthesia  1  21/345 (6.09%)  23 33/340 (9.71%)  36
Neuropathy peripheral  1  19/345 (5.51%)  21 15/340 (4.41%)  15
Psychiatric disorders     
Anxiety  1  13/345 (3.77%)  13 18/340 (5.29%)  22
Depression  1  28/345 (8.12%)  28 31/340 (9.12%)  33
Respiratory, thoracic and mediastinal disorders     
Cough  1  57/345 (16.52%)  78 42/340 (12.35%)  60
Dyspnoea  1  29/345 (8.41%)  35 30/340 (8.82%)  33
Pharyngolaryngeal pain  1  18/345 (5.22%)  28 29/340 (8.53%)  35
Skin and subcutaneous tissue disorders     
Skin ulcer  1  21/345 (6.09%)  25 21/340 (6.18%)  28
Vascular disorders     
Hypertension  1  58/345 (16.81%)  58 50/340 (14.71%)  50
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: info@chroma-derm.com
Organization: Chromaderm
EMail: info@chroma-derm.com
Layout table for additonal information
Responsible Party: Chromaderm, Inc.
ClinicalTrials.gov Identifier: NCT00604383    
Other Study ID Numbers: 4743
B7A-MC-MBCM ( Other Identifier: Eli Lilly and Company )
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: December 22, 2015
Results First Posted: January 28, 2016
Last Update Posted: October 6, 2016