Phase 3
Completed N=496
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
Source: ClinicalTrials.gov NCT00472303 ↗Enrolled (actual)
496
Serious AEs
7.2%
Results posted
May 2014
Primary outcomePrimary: Number of Participants Scored as Responder in Maintenance Phase. — 65; 75; 55 participants
Summary
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR).
*Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Scored as Responder in Maintenance Phase. |
65; 75; 55 | — |
| SECONDARY Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm. |
6.315; 5.324; 4.021 | — |
| SECONDARY Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm. |
6.162; 4.906; 3.669 | — |
| SECONDARY Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase. |
3.198; 2.928; 2.928; 3.220; 3.115; 2.903 | — |
| SECONDARY Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm. |
6.344; 5.326; 4.049 | — |
| SECONDARY Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm. |
6.258; 4.937; 3.690 | — |
| SECONDARY Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase. |
3.1444; 2.8686; 2.832; 3.0869; 3.0073; 2.780 | — |
| SECONDARY Use of Rescue Medication in the Titration Phase. |
241; 91 | — |
| SECONDARY Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase |
75; 67; 80 | — |
| SECONDARY The Average Mean Total Daily Dose of Rescue Medication. |
13.31; 8.87; 11.2; 13.65; 8.91 | — |
| SECONDARY Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase. |
1.3; 1.1; 2.0; 3.1 | — |
| SECONDARY Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase. |
-0.4; -2.164; -1.5; -1.1; -0.671; -0.9 | — |
| SECONDARY Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration. |
0.093; 0.131 | — |
| SECONDARY Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase. |
3.8; 5.6 | — |
| SECONDARY Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms. |
-0.0626; -0.058 | — |
| SECONDARY Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase. |
-2.1; -0.6; -1.5 | — |
| SECONDARY Patient Global Impression of Change |
4; 6; 6; 29; 23; 31 | — |
| SECONDARY Quality of Sleep (Sleep Questionnaire) in the Titration Phase. |
9; 4; 12; 3; 77; 47 | — |
| SECONDARY Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial. |
8; 2; 4; 8; 9; 8 | — |
| SECONDARY Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase. |
7; 5; 8; 0; 1; 1 | — |
| SECONDARY Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase. |
19; 23; 21; 7; 6; 8 | — |
| SECONDARY Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase |
-0.062; -0.076; 0.059; -0.006; 0.02; 0.13 | — |
| SECONDARY Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase |
-0.105; 0.026; -0.075; 0.017; 0.014; -0.033 | — |
Eligibility Criteria
Inclusion Criteria
- Male and non-pregnant, non-lactating female subjects.
- Of at least 18 years of age with chronic malignant tumor-related pain with a mean pain intensity (NRS) of 5 points or higher.
- Subjects who are opioid-naïve or pretreated with an equianalgesic dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.
- Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the trial.
- Expected course of the disease and the pain that would permit compliance with the trial protocol over the entire trial period.
Exclusion Criteria
Key Exclusion Criteria
- Subjects will be excluded from the study if they have a history of seizure disorder or epilepsy;
- known history and/or presence of cerebral tumor or cerebral metastases.
- history of alcohol or drug abuse;
- uncontrolled hypertension,
- clinical laboratory values reflecting severe renal insufficiency,
- moderate or severe hepatic impairment,
- hepatitis B or C, HIV,
- inadequate bone marrow reserve
- currently treated with radiotherapy,
- pain-inducing chemotherapy,
- anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitor (SNRI) or any other analgesic therapy than investigational medication or rescue medication during the trial.
- selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose.
Data sourced from ClinicalTrials.gov (NCT00472303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.