E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary dysmenorrhoea requiring analgesia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036689 |
E.1.2 | Term | Primary dysmenorrhoea |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To determine the efficacy of intra-vaginal mefenamic acid 80 mg (PSD508) on menstrual-related pain, and to compare it with oral mefenamic acid 500 mg, in normal healthy female subjects with menstrual-related pain during menses. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of PSD508 in normal healthy female subjects with menstrual-related pain during menses. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The study population will be normal healthy menstruating female volunteers. Subjects will have a self reported history of primary dysmenorrhoea that includes menstrual related pain with cramping for which they require analgesics.
Inclusion Criteria: A subject will be invited to participate if she meets the following inclusion criteria: 1. Is a healthy menstruating female with a history of primary dysmenorrhoea. 2. Has menstrual-related pain with cramping for which she requires the use of analgesics during each cycle. 3. Has regular menstrual cycles. 4. Routinely uses intra-vaginal tampons and is able to use tampons without an applicator. 5. Is aged 18 – 40 years inclusive. 6. Has no clinically significant medical history and normal clinical examination other than the underlying pathology requiring treatment, in the opinion of the Investigator. 7. Is able to understand and complete the rating scales. 8. Has provided written informed consent.
|
|
E.4 | Principal exclusion criteria |
Exclusion Criteria: A subject will be excluded from study participation if she meets any of the following criteria: 1. Has a history of, or known, hypersensitivity to mefenamic acid. 2. Has a history of reactions such as asthma, urticaria, or allergic type reactions to other non-steroidal anti-inflammatory drugs (NSAIDs). 3. Has received another investigational product within 3 months prior to screening. 4. Is unwilling to avoid the use of any 1) opiate within 24 hours, 2) NSAID within 6 hours, or 3) paracetamol within 4 hours, of starting study medication. [Up to 16 mg codeine per dose (i.e., 2 co-codamol 8/500 mg tablets) is allowed] 5. Is pregnant, lactating, or is planning to become pregnant during the study. 6. Is currently receiving or has received any hormonal contraception within the previous 3 months. 7. Does not agree to use suitable non-hormonal contraception for the duration of the study. 8. Has a history of toxic shock syndrome (TSS) 9. Has a current untreated STD that could interfere with the study. 10. Has, or has had, ulcerative, vesicular or papillomatous lesions of the cervix, vagina or genital area. 11. Is known not to respond to mefenamic acid. 12. Has signs or symptoms that contraindicate the administration of mefenamic acid. 13. Has unresolved alcohol or drug abuse. 14. Has severe menorrhagia which, in the opinion of the investigator, could interfere with the study. 15. Is using complementary therapy, such as evening primrose oil, for the treatment of symptoms. 16. Has any other condition which, in the opinion of the investigator, may interfere with the study.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: The primary efficacy variable is the Summed Pain Intensity Difference over 8 hours (SPID-8) after the first treatment. The Pain Intensity Difference (PID) at each post-treatment time-point is calculated as the pain intensity at that time-point minus the pain intensity at baseline. SPID-8 is then the weighted sum of PID over the 8 hours after the first tampon. Secondary efficacy variables include the Total Pain Relief over the 8 hours following the first tampon (TOTPAR-8), global assessment of efficacy, degree of interference with daily activities, drug preference rating, and rescue medication usage. Safety: AEs, serious adverse events (SAEs), vital signs and physical examination will be recorded. Pharmacokinetics: None
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |