DROPS: To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Sponsor
Rigel Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01900249
Collaborator
(none)
204
20
3
12
10.2
0.9
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
204 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Study Start Date
:
Jul 1, 2013
Actual Primary Completion Date
:
Jul 1, 2014
Actual Study Completion Date
:
Jul 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2% |
Drug: R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
Other Names:
|
| Active Comparator: R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5% |
Drug: R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
Other Names:
|
| Placebo Comparator: Placebo Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. |
Drug: Placebo
Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- Change of Corneal Fluorescein Staining of the Inferior Cornea Region. [Baseline to Week 12]
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
A history of dry eye (based on the date of initial dry eye symptoms)
-
Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
-
Corneal fluorescein staining score of at least 2 in the inferior region
Exclusion Criteria:
-
History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
-
Use of ophthalmic cyclosporine within 45 days of Visit 1.
-
Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
-
Have worn contact lenses or anticipate using contact lenses during the study.
-
Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
-
Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sall Research Medical Center | Artesia | California | United States | 90701 |
| 2 | North Bay Eye | Petaluma | California | United States | 94954 |
| 3 | Martel Medical Eye Group | Rancho Cardova | California | United States | 95670 |
| 4 | Specialty Eye Care | Parker | Colorado | United States | 808134 |
| 5 | International Research Center | Brandon | Florida | United States | 33603 |
| 6 | East Florida Eye Institute | Stuart | Florida | United States | 34994 |
| 7 | Clayton Eye Center | Morrow | Georgia | United States | 30260 |
| 8 | Coastal Research Associates | Roswell | Georgia | United States | 30076 |
| 9 | Chicago Research Center | Chicago | Illinois | United States | 60634 |
| 10 | Chicago Cornea Consultants | Hoffman Estates | Illinois | United States | 60169 |
| 11 | Koffler Vision Group | Lebanon | Kentucky | United States | 40033 |
| 12 | Taustine Eye Center | Louisville | Kentucky | United States | 40217 |
| 13 | Comprehensive Eye Care, Ltd/Vision Research Institute, LLC | Washington | Missouri | United States | 63090 |
| 14 | Mundorf Eye Center | Charlotte | North Carolina | United States | 28204 |
| 15 | Charlotte Eye Ear Nose and Throat Associates, PA | Charlotte | North Carolina | United States | 28210 |
| 16 | Cornerstone Eyecare | High Point | North Carolina | United States | 27262 |
| 17 | Abrams Eye Center | Cleveland | Ohio | United States | 44115 |
| 18 | Glaucoma Consultants and Center for Eye Research | Mt. Pleasant | South Carolina | United States | 29464 |
| 19 | Chattanooga Eye Institute | Chattanooga | Tennessee | United States | 37411 |
| 20 | Eye Clinics of South Texas | San Antonio | Texas | United States | 78209 |
Sponsors and Collaborators
- Rigel Pharmaceuticals
Investigators
- Study Director: Daniel Magilavy, MD, Rigel Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01900249
Other Study ID Numbers:
- C-932348-003
First Posted:
Jul 16, 2013
Last Update Posted:
Oct 3, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo |
|---|---|---|---|
| Arm/Group Description | R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. | R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. |
| Period Title: Overall Study | |||
| STARTED | 67 | 68 | 69 |
| COMPLETED | 64 | 63 | 65 |
| NOT COMPLETED | 3 | 5 | 4 |
Baseline Characteristics
| Arm/Group Title | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. | R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. | Total of all reporting groups |
| Overall Participants | 67 | 68 | 69 | 204 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
62.4
(11.59)
|
63.3
(11.5)
|
61.5
(15.2)
|
62.4
(12.8)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
54
80.6%
|
54
79.4%
|
54
78.3%
|
162
79.4%
|
| Male |
13
19.4%
|
14
20.6%
|
15
21.7%
|
42
20.6%
|
Outcome Measures
| Title | Change of Corneal Fluorescein Staining of the Inferior Cornea Region. |
|---|---|
| Description | Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea. |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population. |
| Arm/Group Title | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo |
|---|---|---|---|
| Arm/Group Description | R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. | R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. |
| Measure Participants | 67 | 68 | 69 |
| Mean (95% Confidence Interval) [units on a scale (Likert)] |
-1.00
|
-0.78
|
-0.78
|
Adverse Events
| Time Frame | The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo | |||
| Arm/Group Description | R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks. | R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks. | Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks. Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. | |||
All Cause Mortality |
||||||
| R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/67 (4.5%) | 1/68 (1.5%) | 2/69 (2.9%) | |||
| Gastrointestinal disorders | ||||||
| Rectal haemorrhage | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Pancreatitis | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| General disorders | ||||||
| Malignant hyperthermia | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Chest pain | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Infections and infestations | ||||||
| Pneumonia | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Intervertebral disc protrusion | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Arthralgia | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Nervous system disorders | ||||||
| Cerebrovascular accident | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| R348 Ophthalmic Solution, 0.2% | R348 Ophthalmic Solution, 0.5% | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/67 (53.7%) | 46/68 (67.6%) | 31/69 (44.9%) | |||
| Cardiac disorders | ||||||
| Cardiac Failure Congestive | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Sinus Tachycardia | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Eye disorders | ||||||
| Eye Discharge | 3/67 (4.5%) | 3 | 3/68 (4.4%) | 3 | 2/69 (2.9%) | 2 |
| Conjunctival Hyperaemia | 0/67 (0%) | 0 | 2/68 (2.9%) | 2 | 0/69 (0%) | 0 |
| Blepharitis | 1/67 (1.5%) | 1 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Chalazion | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Conjunctival Haemorrhage | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Meibomianitis | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Periorbital Oedema | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Ocular Hyperaemia | 3/67 (4.5%) | 3 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Conjunctival Cyst | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Conjunctival Disorder | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Conjunctivitis Allergic | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Eye Pain | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Punctate Keratitis | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Trichiasis | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Lacrimation Increased | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 2/69 (2.9%) | 3 |
| Corneal Abrasion | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Keratitis | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Photophobia | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Gastrointestinal disorders | ||||||
| Diarrhoea | 1/67 (1.5%) | 1 | 2/68 (2.9%) | 2 | 1/69 (1.4%) | 1 |
| Vomiting | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 1/69 (1.4%) | 1 |
| Abdominal Pain | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Gastrooesophageal Reflux Disease | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Nausea | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Pancreatitis | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Rectal Haemorrhage | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Salivary Duct Obstruction | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Toothache | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| General disorders | ||||||
| Instillation Site Pain | 17/67 (25.4%) | 20 | 35/68 (51.5%) | 37 | 3/69 (4.3%) | 3 |
| Instillation Site Pruritus | 1/67 (1.5%) | 1 | 4/68 (5.9%) | 4 | 0/69 (0%) | 0 |
| Chest Pain | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 1/69 (1.4%) | 1 |
| Fatigue | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| instillation Site Paraesthesia | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Instillation Site Discomfort | 4/67 (6%) | 5 | 0/68 (0%) | 0 | 2/69 (2.9%) | 2 |
| Hyperthermia Malignant | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Immune system disorders | ||||||
| Hypersensitivity | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Infections and infestations | ||||||
| Urinary Track Infection | 1/67 (1.5%) | 1 | 2/68 (2.9%) | 2 | 1/69 (1.4%) | 1 |
| Influenza | 0/67 (0%) | 0 | 2/68 (2.9%) | 2 | 2/69 (2.9%) | 2 |
| Sinusitis | 1/67 (1.5%) | 1 | 1/68 (1.5%) | 1 | 1/69 (1.4%) | 1 |
| Upper Respiratory Tract Infection | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 2/69 (2.9%) | 2 |
| Tooth Abscess | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 1/69 (1.4%) | 1 |
| Herpes Zoster | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Nasopharyngitis | 2/67 (3%) | 2 | 0/68 (0%) | 0 | 2/69 (2.9%) | 2 |
| Pneumonia | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Bronchitis | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Hordeolum | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Kidney Infection | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Pharyngitis | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Sinusitis Bacterial | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Post Procedural Infection | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 2 |
| Cystitis | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Otitis Media | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Tooth Fracture | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Contusion | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Fall | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Injury | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Investigations | ||||||
| Blood Pressure Increased | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 1/69 (1.4%) | 1 |
| Urine Analysis Abnormal | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Intraocular Pressure Increased | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Manifest Refraction | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Hyperkalaemia | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Musculoskeletal Pain | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Neck Pain | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Rotator Cuff Syndrome | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Back Pain | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Bursitis | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Systemic Lupus Erythematosus | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Intervertebral Disc Protusion | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 2 |
| Arthralgia | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Basal Cell Carcinoma | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Nervous system disorders | ||||||
| Dysgeusia | 0/67 (0%) | 0 | 2/68 (2.9%) | 2 | 0/69 (0%) | 0 |
| Dizziness | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Viith Nerve Paralysis | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Cerebrovascular Accident | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Headache | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Psychiatric disorders | ||||||
| Depression | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Glycosuria | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Nasal Discomfort | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Oropharyngeal Pain | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Rhinorrhoea | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Asthma | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Atelectasis | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Sinus Congestion | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Cough | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 2/69 (2.9%) | 2 |
| Nasal Congestion | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Erythema | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Acne | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Ecchymosis | 0/67 (0%) | 0 | 0/68 (0%) | 0 | 1/69 (1.4%) | 1 |
| Surgical and medical procedures | ||||||
| Tooth Extraction | 0/67 (0%) | 0 | 1/68 (1.5%) | 1 | 0/69 (0%) | 0 |
| Rotator Cuff Repair | 1/67 (1.5%) | 1 | 0/68 (0%) | 0 | 0/69 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 1/67 (1.5%) | 1 | 2/68 (2.9%) | 2 | 0/69 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Anne-Marie Duliege, MD |
|---|---|
| Organization | Rigel |
| Phone | 650-624-1100 |
| clinicaltrials@rigel.com |
Responsible Party:
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01900249
Other Study ID Numbers:
- C-932348-003
First Posted:
Jul 16, 2013
Last Update Posted:
Oct 3, 2016
Last Verified:
Aug 1, 2016