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Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain

Phase 3
18 Years
Not Enrolling
Analgesics, Opioid, Pain

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Trial Information

Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain

Study DO-118X was a phase-3, multicenter, open-label extension study in adult patients with
cancer pain who had successfully completed Study DO-118 with dose-stable pain control taking
at least 8 mg of OROS hydromorphone (slow release) or its equivalent morphine sulfate SR
(slow release) dosage. Patients were started on the dose of OROS hydromorphone equivalent
to the opioid dose on which they had achieved dose-stable pain control in the SR (slow
release) phase of Study DO-118. Patients returned to their study clinic once a month for 1
year. Dosage adjustments to study medications and breakthrough pain medication were
permitted. OROS hydromorphone HCI (slow release) tablets in 8, 16, 32 and 64mg doses
administered orally every 24 hours

Inclusion Criteria:

- Patients who have chronic cancer pain, and who have successfully completed the OROS
hydromorphone SR (slow release) study, DO-118

- Patients must have been in dose-stable pain control in the last two days of the slow
release phase of the study

- Patients who require at least 8mg of OROS hydromorphone slow release every 24 hours
for the management of chronic cancer pain

Exclusion Criteria:

- Pain which is not considered to be potentially responsive to opioids

- Gastrointestinal disease of sufficient severity to be likely to interfere with oral
analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due
to impaction within the 5 days prior to the start of the trial, severe gut narrowing
that may affect the absorption or transit of orally administered drugs, particularly
the insoluble OROS outer coating

- Any patient in whom the risks of treatment with hydromorphone outweigh the potential
benefits. Such risk categories include: raised intracranial pressure, hypotension,
hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic
impairment, renal impairment, elderly and debilitated, convulsive disorders and
Addison's disease

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study results indicated that long-term treatment with OROS hydromorphone can be useful in the management of persistent, moderate-to-severe chronic pain in patients with cancer

Principal Investigator

Alza Corporation Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

Completion Date:

April 2002

Related Keywords:

  • Analgesics, Opioid
  • Pain
  • Chronic cancer pain
  • OROS hydromorphone HCI (slow release)
  • long-term repeated dosing