MUST: Safety Trial of Naproxen Sodium/ Diphenhydramine
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT01365052
Collaborator
(none)
326
19
2
2
17.2
8.6
Study Details
Study Description
Brief Summary
The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
326 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population
Study Start Date
:
May 1, 2011
Actual Primary Completion Date
:
Jul 1, 2011
Actual Study Completion Date
:
Jul 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
|
Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
|
| Placebo Comparator: Placebo
|
Drug: Placebo
2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product [10 days after randomization]
Please see further details in Adverse Events (AE) section
- Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product [10 days after randomization]
Please see further details in AE section
Other Outcome Measures
- Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product [10 days after randomization]
- Treatment Compliance - Number of Capsules Taken [10 days after randomization]
- Treatment Compliance - Duration of Exposure to Treatment in Days [10 days after randomization]
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy, ambulatory, male and female volunteers ages 12 and older
-
History of experiencing occasional sleeplessness accompanied by aches and pains at least two times, but not continually for more than 14 days per month, in at least 2 of the past 3 months
-
Female subjects of childbearing potential must be using a medically acceptable form of birth control, e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, for at least 1 month prior to screening (3 months on oral contraceptives), or double-barrier and have a negative pregnancy test at Screening. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy
-
Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
-
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects <18 years of age must sign a written assent and have parental or guardian consent).
Exclusion Criteria:
-
History of hypersensitivity to naproxen sodium, acetaminophen, or any NSAIDs (Nonsteroidal Antiinflammatory Drugs), diphenhydramine or any other antihistamines, and similar pharmacological agents or components of the product
-
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies with the last 5 years
-
A history of a chronic or severe sleep problem which does not respond to OTC (Over-the-counter) medication and/or requires a prescription hypnotic or sedative
-
Currently experiencing chronic pain or on chronic NSAID therapy (defined as taking a daily [5 to 7 days per week] regimen of prescription or OTC NSAIDs)
-
Current or past history of gastrointestinal ulcers or bleeding or other bleeding disorders
-
Use of any OTC or prescription medications with which the administration of naproxen, acetaminophen, or any NSAIDs, diphenhydramine or any other antihistamines or sedatives, is contraindicated
-
Chronic use of other products containing diphenhydramine, including topical products
-
Use of steroids or blood thinning (anticoagulant) drugs (aspirin 81 mg is permitted if the dose has been taken for at least one month prior to screening)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chandler | Arizona | United States | 85224 | |
| 2 | Mesa | Arizona | United States | 85203 | |
| 3 | Peoria | Arizona | United States | 85381 | |
| 4 | Anaheim | California | United States | 92801 | |
| 5 | Rancho Cucamonga | California | United States | 91730 | |
| 6 | Sacramento | California | United States | 95816 | |
| 7 | Colorado Springs | Colorado | United States | 80922 | |
| 8 | Kissimmee | Florida | United States | 34741 | |
| 9 | Pembroke Pines | Florida | United States | 33028 | |
| 10 | South Miami | Florida | United States | 33143 | |
| 11 | Stockbridge | Georgia | United States | 30281 | |
| 12 | Metairie | Louisiana | United States | 70006 | |
| 13 | Elkridge | Maryland | United States | 21075 | |
| 14 | Warwick | Rhode Island | United States | 02886 | |
| 15 | Mt. Pleasant | South Carolina | United States | 29464 | |
| 16 | Fort Worth | Texas | United States | 76135 | |
| 17 | San Angelo | Texas | United States | 76904 | |
| 18 | San Antonio | Texas | United States | 78231 | |
| 19 | Salt Lake City | Utah | United States | 84106 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT01365052
Other Study ID Numbers:
- 15560
First Posted:
Jun 3, 2011
Last Update Posted:
Jun 8, 2015
Last Verified:
May 1, 2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo |
|---|---|---|
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days |
| Period Title: Overall Study | ||
| STARTED | 217 | 109 |
| COMPLETED | 213 | 105 |
| NOT COMPLETED | 4 | 4 |
Baseline Characteristics
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days | Total of all reporting groups |
| Overall Participants | 217 | 109 | 326 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46.9
(18.14)
|
47.1
(19.26)
|
47.0
(18.49)
|
| Age, Customized (Number) [Number] | |||
| <60 years |
152
(70.0)
70%
|
72
(66.1)
66.1%
|
224
68.7%
|
| Greater than or equal to 60 years |
65
(30.0)
30%
|
37
(33.9)
33.9%
|
102
31.3%
|
| >65 years |
46
(21.2)
21.2%
|
28
(25.7)
25.7%
|
74
22.7%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
133
61.3%
|
65
59.6%
|
198
60.7%
|
| Male |
84
38.7%
|
44
40.4%
|
128
39.3%
|
Outcome Measures
| Title | Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product |
|---|---|
| Description | |
| Time Frame | 10 days after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo |
|---|---|---|
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days |
| Measure Participants | 217 | 109 |
| Number [Percentage of participants] |
1.8
0.8%
|
3.7
3.4%
|
| Title | Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product |
|---|---|
| Description | Please see further details in Adverse Events (AE) section |
| Time Frame | 10 days after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo |
|---|---|---|
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days |
| Measure Participants | 217 | 109 |
| Number [Percentage of participants] |
39.6
18.2%
|
45.0
41.3%
|
| Title | Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product |
|---|---|
| Description | Please see further details in AE section |
| Time Frame | 10 days after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo |
|---|---|---|
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days |
| Measure Participants | 217 | 109 |
| Number [Percentage of participants] |
0
0%
|
0
0%
|
| Title | Treatment Compliance - Number of Capsules Taken |
|---|---|
| Description | |
| Time Frame | 10 days after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo |
|---|---|---|
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days |
| Measure Participants | 217 | 109 |
| Mean (Standard Deviation) [Capsules] |
20.1
(1.73)
|
19.9
(2.98)
|
| Title | Treatment Compliance - Duration of Exposure to Treatment in Days |
|---|---|
| Description | |
| Time Frame | 10 days after randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo |
|---|---|---|
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days |
| Measure Participants | 217 | 109 |
| Mean (Standard Deviation) [Days] |
9.9
(0.76)
|
9.8
(1.37)
|
Adverse Events
| Time Frame | Treatment emergent adverse events (TEAEs) were collected from the date of the first dose of study drug in the treatment period for 12 days, or for 30 days after the last study drug administration if they were serious adverse events (SAEs). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo | ||
| Arm/Group Description | 2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days | 2 over-encapsulated tablets of placebo are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days | ||
All Cause Mortality |
||||
| Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/217 (0%) | 0/109 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 86/217 (39.6%) | 49/109 (45%) | ||
| Blood and lymphatic system disorders | ||||
| ANISOCYTOSIS | 0/217 (0%) | 1/109 (0.9%) | ||
| HYPOCHROMASIA | 0/217 (0%) | 1/109 (0.9%) | ||
| MICROCYTOSIS | 0/217 (0%) | 1/109 (0.9%) | ||
| Cardiac disorders | ||||
| ANGINA PECTORIS | 0/217 (0%) | 1/109 (0.9%) | ||
| Eye disorders | ||||
| EYE SWELLING | 1/217 (0.5%) | 0/109 (0%) | ||
| VISION BLURRED | 1/217 (0.5%) | 0/109 (0%) | ||
| Gastrointestinal disorders | ||||
| ABDOMINAL DISCOMFORT | 5/217 (2.3%) | 2/109 (1.8%) | ||
| ABDOMINAL PAIN UPPER | 3/217 (1.4%) | 3/109 (2.8%) | ||
| CONSTIPATION | 1/217 (0.5%) | 1/109 (0.9%) | ||
| DIARRHOEA | 7/217 (3.2%) | 2/109 (1.8%) | ||
| DRY MOUTH | 1/217 (0.5%) | 1/109 (0.9%) | ||
| DYSPEPSIA | 5/217 (2.3%) | 1/109 (0.9%) | ||
| DYSPHAGIA | 1/217 (0.5%) | 0/109 (0%) | ||
| FAECES DISCOLOURED | 1/217 (0.5%) | 0/109 (0%) | ||
| FLATULENCE | 1/217 (0.5%) | 0/109 (0%) | ||
| FREQUENT BOWEL MOVEMENTS | 1/217 (0.5%) | 0/109 (0%) | ||
| GASTROOESOPHAGEAL REFLUX DISEASE | 1/217 (0.5%) | 0/109 (0%) | ||
| NAUSEA | 9/217 (4.1%) | 1/109 (0.9%) | ||
| OESOPHAGEAL DISCOMFORT | 1/217 (0.5%) | 0/109 (0%) | ||
| OESOPHAGEAL OEDEMA | 1/217 (0.5%) | 0/109 (0%) | ||
| OESOPHAGEAL PAIN | 1/217 (0.5%) | 0/109 (0%) | ||
| TOOTH LOSS | 1/217 (0.5%) | 0/109 (0%) | ||
| TOOTHACHE | 3/217 (1.4%) | 2/109 (1.8%) | ||
| VOMITING | 1/217 (0.5%) | 0/109 (0%) | ||
| General disorders | ||||
| ASTHENIA | 2/217 (0.9%) | 1/109 (0.9%) | ||
| EARLY SATIETY | 1/217 (0.5%) | 0/109 (0%) | ||
| FATIGUE | 2/217 (0.9%) | 0/109 (0%) | ||
| OEDEMA PERIPHERAL | 1/217 (0.5%) | 0/109 (0%) | ||
| PAIN | 2/217 (0.9%) | 1/109 (0.9%) | ||
| PYREXIA | 1/217 (0.5%) | 0/109 (0%) | ||
| SWELLING | 1/217 (0.5%) | 0/109 (0%) | ||
| THIRST | 2/217 (0.9%) | 0/109 (0%) | ||
| Immune system disorders | ||||
| HYPERSENSITIVITY | 1/217 (0.5%) | 0/109 (0%) | ||
| SEASONAL ALLERGY | 1/217 (0.5%) | 0/109 (0%) | ||
| Infections and infestations | ||||
| NASOPHARYNGITIS | 0/217 (0%) | 1/109 (0.9%) | ||
| PHARYNGITIS STREPTOCOCCAL | 1/217 (0.5%) | 0/109 (0%) | ||
| RHINITIS | 1/217 (0.5%) | 0/109 (0%) | ||
| UPPER RESPIRATORY TRACT INFECTION | 1/217 (0.5%) | 0/109 (0%) | ||
| URINARY TRACT INFECTION | 2/217 (0.9%) | 1/109 (0.9%) | ||
| VULVOVAGINAL MYCOTIC INFECTION | 0/217 (0%) | 1/109 (0.9%) | ||
| Injury, poisoning and procedural complications | ||||
| CONTUSION | 1/217 (0.5%) | 0/109 (0%) | ||
| EXCORIATION | 1/217 (0.5%) | 0/109 (0%) | ||
| LACERATION | 1/217 (0.5%) | 0/109 (0%) | ||
| MUSCLE STRAIN | 1/217 (0.5%) | 1/109 (0.9%) | ||
| Investigations | ||||
| ALANINE AMINOTRANSFERASE ABNORMAL | 1/217 (0.5%) | 0/109 (0%) | ||
| ALANINE AMINOTRANSFERASE INCREASED | 1/217 (0.5%) | 0/109 (0%) | ||
| ASPARTATE AMINOTRANSFERASE INCREASED | 1/217 (0.5%) | 0/109 (0%) | ||
| BASOPHIL COUNT INCREASED | 0/217 (0%) | 1/109 (0.9%) | ||
| BLOOD CREATININE INCREASED | 1/217 (0.5%) | 0/109 (0%) | ||
| BLOOD GLUCOSE INCREASED | 1/217 (0.5%) | 0/109 (0%) | ||
| BLOOD POTASSIUM INCREASED | 2/217 (0.9%) | 0/109 (0%) | ||
| BLOOD UREA INCREASED | 1/217 (0.5%) | 0/109 (0%) | ||
| BLOOD URINE PRESENT | 2/217 (0.9%) | 1/109 (0.9%) | ||
| HAEMATOCRIT DECREASED | 0/217 (0%) | 1/109 (0.9%) | ||
| HAEMOGLOBIN DECREASED | 0/217 (0%) | 1/109 (0.9%) | ||
| HEART RATE INCREASED | 1/217 (0.5%) | 0/109 (0%) | ||
| LYMPHOCYTE COUNT INCREASED | 0/217 (0%) | 1/109 (0.9%) | ||
| NEUTROPHIL COUNT INCREASED | 0/217 (0%) | 1/109 (0.9%) | ||
| RED BLOOD CELL COUNT INCREASED | 0/217 (0%) | 1/109 (0.9%) | ||
| RED BLOOD CELLS URINE | 1/217 (0.5%) | 0/109 (0%) | ||
| URINARY SEDIMENT PRESENT | 1/217 (0.5%) | 2/109 (1.8%) | ||
| WEIGHT INCREASED | 1/217 (0.5%) | 0/109 (0%) | ||
| WHITE BLOOD CELL COUNT INCREASED | 1/217 (0.5%) | 1/109 (0.9%) | ||
| WHITE BLOOD CELLS URINE | 1/217 (0.5%) | 0/109 (0%) | ||
| Metabolism and nutrition disorders | ||||
| DECREASED APPETITE | 1/217 (0.5%) | 0/109 (0%) | ||
| FLUID RETENTION | 0/217 (0%) | 1/109 (0.9%) | ||
| GOUT | 1/217 (0.5%) | 1/109 (0.9%) | ||
| HYPERGLYCAEMIA | 2/217 (0.9%) | 1/109 (0.9%) | ||
| HYPERKALAEMIA | 1/217 (0.5%) | 0/109 (0%) | ||
| TYPE 2 DIABETES MELLITUS | 0/217 (0%) | 1/109 (0.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 1/217 (0.5%) | 1/109 (0.9%) | ||
| BACK PAIN | 8/217 (3.7%) | 3/109 (2.8%) | ||
| MUSCLE SPASMS | 0/217 (0%) | 1/109 (0.9%) | ||
| MUSCLE TIGHTNESS | 1/217 (0.5%) | 0/109 (0%) | ||
| MUSCULOSKELETAL PAIN | 1/217 (0.5%) | 1/109 (0.9%) | ||
| MUSCULOSKELETAL STIFFNESS | 1/217 (0.5%) | 0/109 (0%) | ||
| MYALGIA | 2/217 (0.9%) | 0/109 (0%) | ||
| NECK PAIN | 2/217 (0.9%) | 0/109 (0%) | ||
| OSTEOARTHRITIS | 1/217 (0.5%) | 0/109 (0%) | ||
| PAIN IN EXTREMITY | 0/217 (0%) | 4/109 (3.7%) | ||
| Nervous system disorders | ||||
| DIZZINESS | 9/217 (4.1%) | 0/109 (0%) | ||
| DYSGEUSIA | 1/217 (0.5%) | 0/109 (0%) | ||
| HEADACHE | 23/217 (10.6%) | 21/109 (19.3%) | ||
| HYPOAESTHESIA | 1/217 (0.5%) | 1/109 (0.9%) | ||
| LETHARGY | 1/217 (0.5%) | 1/109 (0.9%) | ||
| PSYCHOMOTOR HYPERACTIVITY | 1/217 (0.5%) | 0/109 (0%) | ||
| RESTLESS LEGS SYNDROME | 1/217 (0.5%) | 0/109 (0%) | ||
| SINUS HEADACHE | 1/217 (0.5%) | 0/109 (0%) | ||
| SOMNOLENCE | 10/217 (4.6%) | 4/109 (3.7%) | ||
| Psychiatric disorders | ||||
| ANXIETY | 1/217 (0.5%) | 0/109 (0%) | ||
| DEPRESSION | 1/217 (0.5%) | 0/109 (0%) | ||
| INSOMNIA | 3/217 (1.4%) | 1/109 (0.9%) | ||
| RESTLESSNESS | 3/217 (1.4%) | 1/109 (0.9%) | ||
| Renal and urinary disorders | ||||
| GLYCOSURIA | 1/217 (0.5%) | 0/109 (0%) | ||
| HAEMATURIA | 1/217 (0.5%) | 1/109 (0.9%) | ||
| PYURIA | 0/217 (0%) | 1/109 (0.9%) | ||
| Reproductive system and breast disorders | ||||
| DYSMENORRHOEA | 1/217 (0.5%) | 0/109 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| DRY THROAT | 1/217 (0.5%) | 0/109 (0%) | ||
| DYSPHONIA | 0/217 (0%) | 1/109 (0.9%) | ||
| DYSPNOEA | 0/217 (0%) | 1/109 (0.9%) | ||
| NASAL CONGESTION | 2/217 (0.9%) | 0/109 (0%) | ||
| OROPHARYNGEAL PAIN | 4/217 (1.8%) | 3/109 (2.8%) | ||
| RHINORRHOEA | 1/217 (0.5%) | 0/109 (0%) | ||
| RHONCHI | 0/217 (0%) | 1/109 (0.9%) | ||
| SINUS CONGESTION | 2/217 (0.9%) | 0/109 (0%) | ||
| SNEEZING | 3/217 (1.4%) | 0/109 (0%) | ||
| UPPER-AIRWAY COUGH SYNDROME | 0/217 (0%) | 1/109 (0.9%) | ||
| Skin and subcutaneous tissue disorders | ||||
| RASH | 1/217 (0.5%) | 0/109 (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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | BAYER |
| Phone | |
| clinical-trials-contact@bayerhealthcare.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT01365052
Other Study ID Numbers:
- 15560
First Posted:
Jun 3, 2011
Last Update Posted:
Jun 8, 2015
Last Verified:
May 1, 2015