Acute Osteoarthritis Experimental Model Study.

NCT01231490 | Completed Phase 2

• 1 other identifier: 111293
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

Brief Summary

This is a methodological study designed to investigate a new model for testing pain agents in the treatment of patients with osteoarthritis (OA). This will be a double-blind, randomised, placebo controlled three-way cross-over study in patients with OA of the knee.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the time to ascend and descend 11 stairs

  Screening, Day 1, Days 8,10,15,17,22,24

Secondary Outcomes (6)

• Pain intensity difference as measured on numerical rating scales (NRS) after ascending and descending 11 stairs.

  Screening, Day 1,Days 8,10,15,17,22,24

• Change from baseline in the time to walk 20, 40 and 100m.

  Screening, Day 1, Days 8,10,15,17,22,24

• Pain intensity difference as measured on a numerical rating scales (NRS) after: 100m walk

  Screening, Day 1, Days 8,10,15,17,22,24

• Pain intensity difference as measured on a numerical rating scales (NRS) after: resting

  Screening,Day 1, Days 2 to 7, 9, 11 to 14, 16, 18 to 21, 23, Days 8,10,15,17,22,24

• Change from baseline in WOMAC scores

  Day 1, Days 8,10,15,17,22,24

Study Arms (2)

Active

EXPERIMENTAL

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Placebo

Naproxen DRUG

Capsule

Active

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of OA of the knee and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Male or female between 50 to 75 years of age inclusive.
• A female subject is eligible to participate if she is of non-childbearing potential defined as:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory\].
• Females with menopausal status ( \> 12 months of spontaneous amenorrhea) and receiving hormone replacement therapy (HRT) treatment for more than 3 months.
• BMI within the range 15-35 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
• Diagnosis
• Have a radiological and clinical diagnosis of OA based upon Arthritis Research Council (ACR) (Appendix 3) criteria affecting at least one knee of a minimum of 3 months in symptom duration prior to screening. An X-ray will be performed at screening if required.
• Have symptomatic OA of at least one knee. The symptoms should be significantly worse in one knee than the other if OA affects both knees.
• When questioned, confirm they experience moderate pain when climbing stairs.
• Be able to walk unaided or with the aid of one stick (2 sticks not allowed)
• A minimum of 4 out 10 on the NRS (numerical rating scales) at screening and/ or a requirement for the use of an analgesic for the pain in the OA knee for most days during the previous three months. In addition, baseline pain must be stable for at least 72 hours prior to day 1 based on patient's assessment or day 1 may be delayed.
• A maximum of 8 out of 10 on the NRS at screening. Enrollement may be delayed if, in the opinion of the investigator, the severity of pain represents an isolated incident.

You may not qualify if:

• General
• The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. However, a positive drug screen will not automatically exclude a subject if there is a valid explanation for the positive result other than drug abuse e.g. poppy seeds.
• History of regular alcohol consumption within 6 months of the study defined as:
• An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
• Intolerance of paracetamol or not response to Non Steriodal Anti Inflammatory Drugs (NSAID) therapy.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of anticoagulants (warfarin, heparin) or anti-platelet aggregation agents (excluding low-dose aspirin) or a condition associated with decreased haemostasis.
• Subject with a known allergy to or judged by the investigator not to be a suitable candidate for naproxen or paracetamol therapy based on medical history, concomitant medications, and concurrent systemic disease as described in the product labelling
• History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. In particular dyspepsia, peptic ulceration, gastrointestinal bleeding, ulcerative colitis or Crohn´s disease
• Presence of anaemia.
• Subjects who have asthma, have received anti-asthmatic medication within the last 5 years, have a history of NSAID-sensitive asthma or who have ever required hospital admission due to asthma.
• Presence of cardiac heart failure NYHA \> 1.
• Presence of hypertension (BP systolic \> 150 mmHg, diastolic \> 90 mmHg) not adequately controlled by antihypertensive treatment.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom

Location

GSK Investigational Site

Cardiff, CF14 5GJ, United Kingdom

Location

GSK Investigational Site

Manchester, M15 6SX, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 31, 2011

Record last verified: 2011-01

Locations

GB (3)