Sponsor: Penwest Pharmaceuticals Company
Study Drug: Nubain-ER (Nalbuphine-ER)
Protocol: NAL20
Phase: IIa
CRO: i 3 Research
Site #:
Screening #
CRA:
Medical Monitor
Study Ends Recruitment:
Central Lab: Quest
IRB: Coast IRB
216 Subjects / 24 Sites -> 9 Subjects per Site R 2:1 to:
Nubain-ER 60-180 BID : vs.
Placebo
RM = Rescue Medication -> Tylenol 500 QID prn between V2-V6
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IC
Age: 40 – 70
OA Hip or Knee X past 6 months including: Pain; Stiffness; or, Crepitus
AND NSAID for 75/90 days prior to screening
AND little or no use of Opioids (Less than or equal to 3 times a week)
Need NPRS more or equals 4 (0-10) Pain Scale on 2 consecutive days -> RTC within 72H for R
EC
Any Pain Med within 3 days of first dose study drug
On Opioids greater than 3x per wk during the past month
Joint Replacement in the index joint or any joint within 2 months
Adjunctive Therapy that is not stable for the past month
Systemic Steroids within 6 wks
Hepatitis B or C
HIV
Any chronic pain, anxiety or depression med
HADS score > 10 either Anxiety or Depression
WC
If fails to have NPRS more or equals 4 during wash out period -> Flunk out & don’t progress to V2
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V1 D -21 Screening Visit, D/C Pain Meds, Electronic Diary; EKG RTC within 72 H of Pain more or equals 4 (0-10) x 2 days
V2 D 1 Lab; Baseline/Randomization Visit, Pain must be ? 4 on the NPRS Scale (0-10) Now! Dispense Nubain-ER 60 mgm BID vs Placebo; RTC 1 wk
V2a If did not qualify for R based on NPRS score but repeat NPRS scores have been ? 4 for two consecutive days; e-diary;
V3 D 7 Lab; ^ Nubain-ER 120 mgm BID (May stay at 60 BID but can’t go up later) RTC 1 week
V4 D 14 Lab; ^ Nubain-ER 180 mgm BID (May stay at 60 BID but can’t go up later) EKG; RTC 1 wk
V5 D 21 Labs: 1) Pre-last dose; 2) more or equald 2 H. post-last dose Daily phone calls between V5-V6 for SOWS; RTC 1 wk
V5a If SOWS abnormal RTC for OOWS & taper narcotic slower
V6 D 28 Final Visit; EKG
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Equianalgesic Dosing
Opioid Interchange of MS 60 mgm Equivalent
Morphine Sulfate (Avinza, Kadian, Nubain) - 60
Tramadol (Ultram) - 600
Hydrocodone (Lortab, Vicodin) - 40
Propoxyphene (Darvocet) - 400
Codeine (Tylenol # 3) - 240
Levorphanol (Levodromoran) - 7.5
Hydromorphone (Dilaudid) - 15
Oxycodone (OxyIR, Oxycontin, Percocet) - 30
Methadone - 7.5
Fentanyl (Duragesic Patch) - 25
Opana (Oxymorphone) - 20
(Opana 5 mgm = 15 mgm MS)
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Questions
Penwest i3 NAL Investigators Meeting May 18-20, 2007 Orlando Expense Sheet