Safety Trial of Naproxen Sodium/ Diphenhydramine

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365052

Acronym

MUST

Enrollment

326

Registered

2011-06-03

Start date

2011-05-31

Completion date

2011-07-31

Last updated

2015-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Maximum Use Safety Trial

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.

Interventions

DRUGNaproxen 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

DRUGPlacebo

2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	217
Placebo 2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days	109
Total	326

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	4	4

Baseline characteristics

Characteristic	Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)	Placebo	Total
Age, Continuous	46.9 years STANDARD_DEVIATION 18.14	47.1 years STANDARD_DEVIATION 19.26	47.0 years STANDARD_DEVIATION 18.49
Age, Customized <60 years	152 Participants 70	72 Participants 66.1	224 Participants
Age, Customized >65 years	46 Participants 21.2	28 Participants 25.7	74 Participants
Age, Customized Greater than or equal to 60 years	65 Participants 30	37 Participants 33.9	102 Participants
Sex: Female, Male Female	133 Participants	65 Participants	198 Participants
Sex: Female, Male Male	84 Participants	44 Participants	128 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	86 / 217	49 / 109
serious Total, serious adverse events	0 / 217	0 / 109