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Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00626275
First received: February 22, 2008
Last updated: December 4, 2008
Last verified: October 2008

February 22, 2008
December 4, 2008
October 2007
September 2008   (final data collection date for primary outcome measure)
Part A (single-dose crossover part): Average difference between baseline and postdose lower extremity pain intensity (LEPI) over 6 hours after repeated treadmill walking. Part B: mean daily LEPI score over 2 weeks. [ Time Frame: 6 hours post dosing and 3xdaily IVRS calls during 2 wks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626275 on ClinicalTrials.gov Archive Site
  • Part A (single-dose crossover): pain intensity score for overall pain, for lower extremity pain, & for evoked (by treadmill walking) lower extremity pain at each scheduled time point. [ Time Frame: 2, 4, or 6 hours ] [ Designated as safety issue: No ]
  • Part B (multiple-dose comparison with placebo): average daily LEPI scores for Weeks 1 & 2; average daily overall pain intensity scores at Week 1 and Week 2 visits and over the 2 week period; proportion of subjects using rescue [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
  • Part A: Pain intensity difference between baseline and the value at each scheduled time point for overall pain, for lower extremity pain, and for evoked lower extremity pain; [ Time Frame: 2, 4, or 6 hours ] [ Designated as safety issue: No ]
  • Part A: the average difference between baseline and postdose evoked lower extremity pain over the 4 hours after dosing [ Time Frame: 4 hours post dosing ] [ Designated as safety issue: No ]
  • Part A: peak evoked lower extremity pain; average difference between baseline and postdose lower extremity pain intensity at rest over the 6 hours after dosing; [ Time Frame: 6 hours post dosing ] [ Designated as safety issue: No ]
  • Part A: percentage of subjects in each treatment group achieving a 25%, 50%, or 75% reduction in evoked lower extremity pain intensity scores at 2, 4, or 6 hours; [ Time Frame: 2, 4, or 6 hours post dosing ] [ Designated as safety issue: No ]
  • Part A: Proportion of subjects able to walk on a treadmill for their target treadmill walking time; subject's global evaluation of study medication [ Time Frame: Week 1 and Week 2 study visits ] [ Designated as safety issue: No ]
  • Part B (multiple-dose comparison with placebo): average daily lower extremity pain intensity scores for Weeks 1 and 2 [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
  • Part B: Average daily overall pain intensity scores at Week 1 and Week 2 visits and over the 2 week period [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
  • Part B: Proportion of subjects using rescue medication; mean dose of rescue medication for Weeks 1 and 2 and over the 2 week period [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
  • Part B: Subject's global evaluation of study medication at Week 1 and Week 2 visits [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
  • Reports of adverse events, and changes in the results of: clinical laboratory tests, vital signs and ECGs [ Time Frame: Trial duration ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid Arthritis
A Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL 5859 in Subjects With Rheumatoid Arthritis

The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single dose compared with multiple doses. The study drug, ADL5859, has not been previously tested in patients with RA; it is anticipated to provide pain relief in RA because it demonstrated effectiveness in animal studies.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: ADL5859
    Four 50-mg ADL5859 opaque, Swedish Orange, capsules (No. 0) as single dose
    Other Name: ADL-5859
  • Drug: naproxen
    Two 250-mg naproxen capsules [each placed in an opaque, Swedish Orange capsule (No. 0) with lactose monohydrate, NF]AND two matching placebo capsules containing lactose monohydrate, NF
    Other Name: Naprosyn
  • Drug: Placebo
    Four opaque, Swedish Orange, capsules (no.0), each containing lactose monohydrate,NF
    Other Names:
    • placebo
    • lactose
  • Drug: ADL5859
    Two 50-mg ADL5859 opaque, Swedish Orange, capsules (no.0) twice daily for 14 days
    Other Name: ADL-5859
  • Drug: Lactose monohydrate, NF
    Two Opaque, Swedish Orange, No.0 capsules containing lactose monohydrate, NF, twice daily
    Other Name: lactose
  • Experimental: A1
    ADL5859
    Intervention: Drug: ADL5859
  • Active Comparator: A2
    500 mg naproxen
    Intervention: Drug: naproxen
  • Placebo Comparator: A3
    Lactose monohydrate, NF
    Intervention: Drug: Placebo
  • Experimental: B1
    ADL5859
    Intervention: Drug: ADL5859
  • Placebo Comparator: B2
    Lactose monohydrate, NF
    Intervention: Drug: Lactose monohydrate, NF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects between 18 and 75 years of age, inclusive
  • Have a documented history of rheumatoid arthritis (diagnosed according to American College of Rheumatology criteria) for at least 6 months before study entry
  • Have painful rheumatoid arthritis with pain predominantly in the lower extremities (ie, hip, knees, ankles, and/or feet)
  • Have a lower extremity pain intensity score of 5 or higher on a pain rating scale completed on Day 1 of Part A before dosing (after resting for 45 minutes and then walking for at least 10 minutes on a treadmill)and then have a minimum ELEPI score of 4 on other visits in Part A
  • If receiving disease modifying antirheumatic drugs, have a stable dose regimen for at least 30 days before study entry (90 days before study entry for biologic therapy)
  • If biologic therapy has been recently discontinued, Enbrel™ or Orencia™ must have been discontinued at least 30 days before study entry, and Humira™, Remicade™, and Rituxan™ must have been discontinued at least 60 days before study entry
  • For male subjects, be surgically sterile or agree to use an appropriate method of contraception
  • For female subjects of childbearing potential, be surgically sterile or using an intrauterine device, or injectable, transdermal, or combination oral contraceptive deemed highly effective by the FDA
  • Have a body weight of at least 45 kg
  • Be able to understand and comply with the protocol requirements (such as repeated treadmill walking and diary completion via the interactive voice response system), instructions, and protocol specified restrictions.

Exclusion Criteria:

  • Have an overall pain intensity score equal to 10 at screening or before the first dose of study medication in Part A
  • Have a pain intensity score for the upper body (ie, back, neck, fingers, wrists, elbows, and/or shoulders) above 7 on a pain rating scale before study medication administration
  • Have a history of headache requiring prescription treatment within 6 months of study entry
  • Have significant renal disease (as indicated by blood urea nitrogen or serum creatinine ≥ 2 times the upper limit of normal) or have significant hepatic disease (as indicated by liver function test results ≥ 2 times the upper limit of normal)
  • Have low blood pressure symptoms when going from a sitting position to standing
  • Have a history of a seizure disorder, including febrile seizures
  • Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that would affect study participation
  • Are taking cytochrome P450 (CYP) 3A4/5 or P glycoprotein (P gp) transporter inhibitors
  • Have taken oral steroids within 30 days of study entry or intra articular steroids within 60 days of study entry (inhaled or topical steroids or stable oral dose ≤ 10 mg is permitted)
  • Have a history or presence of allergy or intolerance to nonsteroidal anti inflammatory drugs or acetaminophen, or have a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study
  • Have a history of alcoholism or drug addiction or abuse within 5 years before the scheduled administration of study medication
  • Have participated in a trial of any investigational medication within 30 days before study drug administration
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00626275
33CL232
No
Bruce Berger, MD, Adolor Corporation
Cubist Pharmaceuticals
Not Provided
Study Director: Bruce Berger, MD Cubist Pharmaceuticals
Cubist Pharmaceuticals
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP