NCT02405793

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a low dose and a high dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due to osteoarthritis of the knee or hip.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

March 27, 2015

Last Update Submit

July 8, 2015

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

    Baseline to Week 6

Secondary Outcomes (13)

  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.

    Baseline to Week 6

  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.

    Baseline to Week 6

  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Symptoms Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.

    Baseline to Week 6

  • Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 3.

    2 hours after dosing on Day 3

  • Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 14.

    2 hours after dosing on Day 14

  • +8 more secondary outcomes

Study Arms (3)

Meloxicam low dose test capsule

EXPERIMENTAL

Meloxicam SoluMatrix Capsules - low dose QD

Drug: Meloxicam Test Capsules

Meloxicam high dose test capsule

EXPERIMENTAL

Meloxicam SoluMatrix Capsules - high dose QD

Drug: Meloxicam Test Capsules

Meloxicam tablets

ACTIVE COMPARATOR

Meloxicam Tablets QD

Drug: Meloxicam Tablets

Interventions

Meloxicam Test CapsulesDRUG
Meloxicam low dose test capsule
Meloxicam TabletsDRUG
Meloxicam tablets

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of Functional Class I-III osteoarthritis (OA) of the hip or knee
  • Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
  • Discontinued all analgesic therapy at Screening
  • For women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
  • Ability to ambulate

You may not qualify if:

  • History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
  • Requires regular (more than 2 doses per week) use of opioid or opioid combination products to control OA pain of the knee or hip
  • Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
  • Significant difficulties swallowing capsules/tablets or unable to tolerate oral medication
  • Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 1, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 10, 2015

Record last verified: 2015-07