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Trial record 60 of 448 for:    diphenhydramine

Safety Trial of Naproxen Sodium/ Diphenhydramine (MUST)

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: NCT01365052
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : June 16, 2014
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator)
Condition Pain
Interventions Drug: Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)
Drug: Placebo
Enrollment 326
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Hide 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
Reason Not Completed
Adverse Event             4             4
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo Total
Hide 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 Number of Baseline Participants 217 109 326
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 217 participants 109 participants 326 participants
46.9  (18.14) 47.1  (19.26) 47.0  (18.49)
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 217 participants 109 participants 326 participants
<60 years 152 72 224
Greater than or equal to 60 years 65 37 102
>65 years 46 28 74
[1]
Measure Description: Some categories will have overlapping samples
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 109 participants 326 participants
Female
133
  61.3%
65
  59.6%
198
  60.7%
Male
84
  38.7%
44
  40.4%
128
  39.3%
1.Primary Outcome
Title Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
Hide Description Please see further details in Adverse Events (AE) section
Time Frame 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Hide 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
Overall Number of Participants Analyzed 217 109
Measure Type: Number
Unit of Measure: Percentage of participants
39.6 45.0
2.Primary Outcome
Title Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
Hide Description Please see further details in AE section
Time Frame 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Hide 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
Overall Number of Participants Analyzed 217 109
Measure Type: Number
Unit of Measure: Percentage of participants
0 0
3.Other Pre-specified Outcome
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
Hide Description [Not Specified]
Time Frame 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Hide 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
Overall Number of Participants Analyzed 217 109
Measure Type: Number
Unit of Measure: Percentage of participants
1.8 3.7
4.Other Pre-specified Outcome
Title Treatment Compliance - Number of Capsules Taken
Hide Description [Not Specified]
Time Frame 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Hide 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
Overall Number of Participants Analyzed 217 109
Mean (Standard Deviation)
Unit of Measure: Capsules
20.1  (1.73) 19.9  (2.98)
5.Other Pre-specified Outcome
Title Treatment Compliance - Duration of Exposure to Treatment in Days
Hide Description [Not Specified]
Time Frame 10 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Hide 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
Overall Number of Participants Analyzed 217 109
Mean (Standard Deviation)
Unit of Measure: Days
9.9  (0.76) 9.8  (1.37)
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 [Not Specified]
 
Arm/Group Title Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/217 (0.00%)   0/109 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   86/217 (39.63%)   49/109 (44.95%) 
Blood and lymphatic system disorders     
ANISOCYTOSIS * 1  0/217 (0.00%)  1/109 (0.92%) 
HYPOCHROMASIA * 1  0/217 (0.00%)  1/109 (0.92%) 
MICROCYTOSIS * 1  0/217 (0.00%)  1/109 (0.92%) 
Cardiac disorders     
ANGINA PECTORIS * 1  0/217 (0.00%)  1/109 (0.92%) 
Eye disorders     
EYE SWELLING * 1  1/217 (0.46%)  0/109 (0.00%) 
VISION BLURRED * 1  1/217 (0.46%)  0/109 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT * 1  5/217 (2.30%)  2/109 (1.83%) 
ABDOMINAL PAIN UPPER * 1  3/217 (1.38%)  3/109 (2.75%) 
CONSTIPATION * 1  1/217 (0.46%)  1/109 (0.92%) 
DIARRHOEA * 1  7/217 (3.23%)  2/109 (1.83%) 
DRY MOUTH * 1  1/217 (0.46%)  1/109 (0.92%) 
DYSPEPSIA * 1  5/217 (2.30%)  1/109 (0.92%) 
DYSPHAGIA * 1  1/217 (0.46%)  0/109 (0.00%) 
FAECES DISCOLOURED * 1  1/217 (0.46%)  0/109 (0.00%) 
FLATULENCE * 1  1/217 (0.46%)  0/109 (0.00%) 
FREQUENT BOWEL MOVEMENTS * 1  1/217 (0.46%)  0/109 (0.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  1/217 (0.46%)  0/109 (0.00%) 
NAUSEA * 1  9/217 (4.15%)  1/109 (0.92%) 
OESOPHAGEAL DISCOMFORT * 1  1/217 (0.46%)  0/109 (0.00%) 
OESOPHAGEAL OEDEMA * 1  1/217 (0.46%)  0/109 (0.00%) 
OESOPHAGEAL PAIN * 1  1/217 (0.46%)  0/109 (0.00%) 
TOOTH LOSS * 1  1/217 (0.46%)  0/109 (0.00%) 
TOOTHACHE * 1  3/217 (1.38%)  2/109 (1.83%) 
VOMITING * 1  1/217 (0.46%)  0/109 (0.00%) 
General disorders     
ASTHENIA * 1  2/217 (0.92%)  1/109 (0.92%) 
EARLY SATIETY * 1  1/217 (0.46%)  0/109 (0.00%) 
FATIGUE * 1  2/217 (0.92%)  0/109 (0.00%) 
OEDEMA PERIPHERAL * 1  1/217 (0.46%)  0/109 (0.00%) 
PAIN * 1  2/217 (0.92%)  1/109 (0.92%) 
PYREXIA * 1  1/217 (0.46%)  0/109 (0.00%) 
SWELLING * 1  1/217 (0.46%)  0/109 (0.00%) 
THIRST * 1  2/217 (0.92%)  0/109 (0.00%) 
Immune system disorders     
HYPERSENSITIVITY * 1  1/217 (0.46%)  0/109 (0.00%) 
SEASONAL ALLERGY * 1  1/217 (0.46%)  0/109 (0.00%) 
Infections and infestations     
NASOPHARYNGITIS * 1  0/217 (0.00%)  1/109 (0.92%) 
PHARYNGITIS STREPTOCOCCAL * 1  1/217 (0.46%)  0/109 (0.00%) 
RHINITIS * 1  1/217 (0.46%)  0/109 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION * 1  1/217 (0.46%)  0/109 (0.00%) 
URINARY TRACT INFECTION * 1  2/217 (0.92%)  1/109 (0.92%) 
VULVOVAGINAL MYCOTIC INFECTION * 1  0/217 (0.00%)  1/109 (0.92%) 
Injury, poisoning and procedural complications     
CONTUSION * 1  1/217 (0.46%)  0/109 (0.00%) 
EXCORIATION * 1  1/217 (0.46%)  0/109 (0.00%) 
LACERATION * 1  1/217 (0.46%)  0/109 (0.00%) 
MUSCLE STRAIN * 1  1/217 (0.46%)  1/109 (0.92%) 
Investigations     
ALANINE AMINOTRANSFERASE ABNORMAL * 1  1/217 (0.46%)  0/109 (0.00%) 
ALANINE AMINOTRANSFERASE INCREASED * 1  1/217 (0.46%)  0/109 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/217 (0.46%)  0/109 (0.00%) 
BASOPHIL COUNT INCREASED * 1  0/217 (0.00%)  1/109 (0.92%) 
BLOOD CREATININE INCREASED * 1  1/217 (0.46%)  0/109 (0.00%) 
BLOOD GLUCOSE INCREASED * 1  1/217 (0.46%)  0/109 (0.00%) 
BLOOD POTASSIUM INCREASED * 1  2/217 (0.92%)  0/109 (0.00%) 
BLOOD UREA INCREASED * 1  1/217 (0.46%)  0/109 (0.00%) 
BLOOD URINE PRESENT * 1  2/217 (0.92%)  1/109 (0.92%) 
HAEMATOCRIT DECREASED * 1  0/217 (0.00%)  1/109 (0.92%) 
HAEMOGLOBIN DECREASED * 1  0/217 (0.00%)  1/109 (0.92%) 
HEART RATE INCREASED * 1  1/217 (0.46%)  0/109 (0.00%) 
LYMPHOCYTE COUNT INCREASED * 1  0/217 (0.00%)  1/109 (0.92%) 
NEUTROPHIL COUNT INCREASED * 1  0/217 (0.00%)  1/109 (0.92%) 
RED BLOOD CELL COUNT INCREASED * 1  0/217 (0.00%)  1/109 (0.92%) 
RED BLOOD CELLS URINE * 1  1/217 (0.46%)  0/109 (0.00%) 
URINARY SEDIMENT PRESENT * 1  1/217 (0.46%)  2/109 (1.83%) 
WEIGHT INCREASED * 1  1/217 (0.46%)  0/109 (0.00%) 
WHITE BLOOD CELL COUNT INCREASED * 1  1/217 (0.46%)  1/109 (0.92%) 
WHITE BLOOD CELLS URINE * 1  1/217 (0.46%)  0/109 (0.00%) 
Metabolism and nutrition disorders     
DECREASED APPETITE * 1  1/217 (0.46%)  0/109 (0.00%) 
FLUID RETENTION * 1  0/217 (0.00%)  1/109 (0.92%) 
GOUT * 1  1/217 (0.46%)  1/109 (0.92%) 
HYPERGLYCAEMIA * 1  2/217 (0.92%)  1/109 (0.92%) 
HYPERKALAEMIA * 1  1/217 (0.46%)  0/109 (0.00%) 
TYPE 2 DIABETES MELLITUS * 1  0/217 (0.00%)  1/109 (0.92%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA * 1  1/217 (0.46%)  1/109 (0.92%) 
BACK PAIN * 1  8/217 (3.69%)  3/109 (2.75%) 
MUSCLE SPASMS * 1  0/217 (0.00%)  1/109 (0.92%) 
MUSCLE TIGHTNESS * 1  1/217 (0.46%)  0/109 (0.00%) 
MUSCULOSKELETAL PAIN * 1  1/217 (0.46%)  1/109 (0.92%) 
MUSCULOSKELETAL STIFFNESS * 1  1/217 (0.46%)  0/109 (0.00%) 
MYALGIA * 1  2/217 (0.92%)  0/109 (0.00%) 
NECK PAIN * 1  2/217 (0.92%)  0/109 (0.00%) 
OSTEOARTHRITIS * 1  1/217 (0.46%)  0/109 (0.00%) 
PAIN IN EXTREMITY * 1  0/217 (0.00%)  4/109 (3.67%) 
Nervous system disorders     
DIZZINESS * 1  9/217 (4.15%)  0/109 (0.00%) 
DYSGEUSIA * 1  1/217 (0.46%)  0/109 (0.00%) 
HEADACHE * 1  23/217 (10.60%)  21/109 (19.27%) 
HYPOAESTHESIA * 1  1/217 (0.46%)  1/109 (0.92%) 
LETHARGY * 1  1/217 (0.46%)  1/109 (0.92%) 
PSYCHOMOTOR HYPERACTIVITY * 1  1/217 (0.46%)  0/109 (0.00%) 
RESTLESS LEGS SYNDROME * 1  1/217 (0.46%)  0/109 (0.00%) 
SINUS HEADACHE * 1  1/217 (0.46%)  0/109 (0.00%) 
SOMNOLENCE * 1  10/217 (4.61%)  4/109 (3.67%) 
Psychiatric disorders     
ANXIETY * 1  1/217 (0.46%)  0/109 (0.00%) 
DEPRESSION * 1  1/217 (0.46%)  0/109 (0.00%) 
INSOMNIA * 1  3/217 (1.38%)  1/109 (0.92%) 
RESTLESSNESS * 1  3/217 (1.38%)  1/109 (0.92%) 
Renal and urinary disorders     
GLYCOSURIA * 1  1/217 (0.46%)  0/109 (0.00%) 
HAEMATURIA * 1  1/217 (0.46%)  1/109 (0.92%) 
PYURIA * 1  0/217 (0.00%)  1/109 (0.92%) 
Reproductive system and breast disorders     
DYSMENORRHOEA * 1  1/217 (0.46%)  0/109 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
DRY THROAT * 1  1/217 (0.46%)  0/109 (0.00%) 
DYSPHONIA * 1  0/217 (0.00%)  1/109 (0.92%) 
DYSPNOEA * 1  0/217 (0.00%)  1/109 (0.92%) 
NASAL CONGESTION * 1  2/217 (0.92%)  0/109 (0.00%) 
OROPHARYNGEAL PAIN * 1  4/217 (1.84%)  3/109 (2.75%) 
RHINORRHOEA * 1  1/217 (0.46%)  0/109 (0.00%) 
RHONCHI * 1  0/217 (0.00%)  1/109 (0.92%) 
SINUS CONGESTION * 1  2/217 (0.92%)  0/109 (0.00%) 
SNEEZING * 1  3/217 (1.38%)  0/109 (0.00%) 
UPPER-AIRWAY COUGH SYNDROME * 1  0/217 (0.00%)  1/109 (0.92%) 
Skin and subcutaneous tissue disorders     
RASH * 1  1/217 (0.46%)  0/109 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01365052     History of Changes
Other Study ID Numbers: 15560
First Submitted: May 17, 2011
First Posted: June 3, 2011
Results First Submitted: January 24, 2014
Results First Posted: June 16, 2014
Last Update Posted: June 8, 2015