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Double-blind, Double-dummy, Randomised, Parallel-Arm Equivalence [Non-Inferiority] Study Comparing Hydromorphone Hydrochloride Extended-Release [HHER] Capsules to MS Contin Tablets, Dosed at a Ratio of 1:7.5 to relieve pain, in Cancer or Non-Cancer Patients with a History of Moderate to Severe Pain

Double-blind, Double-dummy, Randomised, Parallel-Arm Equivalence [Non-Inferiority] Study Comparing Hydromorphone Hydrochloride Extended-Release [HHER] Capsules to MS Contin Tablets, Dosed at a Ratio of 1:7.5 to relieve pain, in Cancer or Non-Cancer Patients with a History of Moderate to Severe Pain

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000696695
Enrollment
168
Registered
2005-10-28
Start date
2001-02-08
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a double-blind, double-dummy, randomised, parallel-arm controlle trial of HHER and MS Contin in patients with a history of chronic moderate to severe cancer or non-cancer pain.

Interventions

Patients with a history of moderate to severe pain [and who have poorly controlled pain] will be randomised to receive either HHER or MS Contin for 7 [+2] days. Aim is to establish that HHER and MS Contin are equivalent [non-inferior] at an equianalgesic dose ratio of 1:7.5

Sponsors

Mundipharma Pty Limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Treatment with opioid analgesic for at least past 4 weeks. 2. Prior opioid analgesic equivalent to 80mg morphine or greater. 3. Pain score less than, or equal to, 4 over 24 hour period for last two consecutive days. 4. Rescue doses less than, or equal to, three doses over 24 hour period for the last two consecutive days.

Exclusion criteria

History of alcohol or drug abuse, unstable pain, high dose systemic corticosteroid therapy excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026